East Midlands Colorectal Cancer Expert Clinical Advisory Group (ECAG) Clinical Guidelines for the Bowel Cancer Care Pathway

Transcription

1 East Midlands Colorectal Cancer Expert Clinical Advisory Group (ECAG) Clinical Guidelines for the Bowel Cancer Care Pathway Reviewed by: Colorectal ECAG August 2014 Ratified by: Colorectal ECAG 2 nd March 2015 Endorsed by: Mr William Speake, ECAG Lead Distributed to: Colorectal ECAG members Trust Lead Cancer Clinicians Cancer Centre Managers Version History: Date: Version: Review: 4 th November 2011 V1 Reviewed July 2012 for Peer review IV panel Review July nd March 2015 V2 March

2 Contents: Page 1.0 Introduction and high level overview of the bowel cancer 3 pathway 2.0 Scope of the operational framework General principles Referral guidelines and process Investigation policies for bowel cancer Flow of clinical responsibilities Surgical treatment guidelines Non surgical oncology Supportive and palliative care Follow-up Family history guidelines Stenting policy Anal cancer guidelines Early rectal cancer guidelines Resection of liver metastases guidelines Lung metastases guidelines Teenage and Young Adult Pathways 54 APPENDIX 1: Policy for Patients with Unexpected Diagnosis 57 APPENDIX 2: Sign off for Colorectal Investigation Protocol 59 APPENDIX 3: Colorectal Risk Stratified Follow up pathway and 61 guidelines. 2

3 1.0 Introduction and high level overview of the bowel cancer pathway Primary Symptomatic patient GP examination (see text) High index of suspicion of cancer [a} Any age: 1. Definite palpable right abdominal or rectal mass 2. Rectal bleeding with change of bowel habit persistent for > 6/52 (Aged >40 years) 3. Unexplained Fe. deficiency anaemia 4. Abdopain only if severe, colicky and in association with weight loss (Emergency admission) 5. A suspicious barium enema or colonoscopy [b] >60 years: 1. Rectal bleeding persistently without anal symptoms for > 6/52 2. Change of bowel habit to looser stools and/or increased frequency of defaecation without rectal bleeding & persistent for > 6/52 Low index of suspicion of cancer But high index of suspicion of inflammatory bowel disease Emergency e.g. any patient with an acute obstruction Secondary Care Urgent Colorectal Cancer Clinic Physical examination & Flexible signmoidoscopy (see text) Appropriate examination of the colon (usually a Colonoscopy) Appropriate surgical / gastroenterology clinic Incidental presentations Clear protocol for hand-over to CRC MDT COLON Ca Colorectal Cancer Confirmed RECTAL Ca. "Non- Early" RECTAL Ca. "Early" ANAL Ca Resuscitate and handover to CRC Surgical Team CT Abdo, Chest & Pelvis MRI Pelvis & CT Abdo & chest & ERUS MRI Pelvis & CT Abdo & chest & ERUS & Refer to pathway on P18 Refer to anal pathway Multi-disciplinary Team Meeting SURGERY Specialist Liver Resection Team Specialist Palliative Care (See text) Oncology Consider Pre-op Chemo Rx/Radio Rx for Rectal Cancers Multi-disciplinary Team Meeting FOLLOW UP See text for fuller details, including surveillance Right person at right time in the right place avoiding prolonged and multi-specialist follow-up Recurrence (See text) Consider consortium follow-up systems that includes Specialist Palliative Care +/- primary / secondary / tertiary care nurses Patients who recur should be fast tracked back into a relevant MDT Patients will have unlimited access to specialist nurses within an appropriate setting (Specialist Palliative Care +/- primary / secondary / tertiary care) 3

4 2.0 Scope of the operational framework This Operational Framework sets out the areas of common policy agreed by the East Midlands Strategic Clinical Network (EMSCN) Colorectal Expert Clinical Advisory Group and constituent local Colorectal Cancer MDTs. This is a working document based on: Revised Improving Outcomes Guidance for Bowel Cancer The Manual of Measures for Cancer Services (2004) and the 2010 update relating to Colorectal Cancer The Cancer Reform Strategy Experience with the guidelines of the three former cancer networks within the East Midlands BSG Recommendations NICE Updates The document will be updated as new evidence is available. 3.0 General principles The document deals with the overall patient pathway. Local Colorectal Cancer MDT Operational Policies will reflect the recommendations made in this Operational Framework but will be tailored to meet local needs. The tumours covered by this Operational Framework are: Cancer of the colon Cancer of the rectum both early and more advanced Cancer of the anus Metastatic disease from these sites in either/both liver and lung 4.0 Referral guidelines and process 4.1 Basis of prioritisation The following protocol outlines the priority that should be given to different types of clinical presentation for investigation of large bowel symptoms. The clinical presentations are in accordance with the National Referral Guidelines for Suspected Cancer and reflected in the Primary Care Referral Proforma. It has been established that General Practitioners do not refer to named clinicians but to the designated diagnostic teams and that endoscopy is the preferred investigation. See Constitution for configuration of services. 4

5 4.1.1 Referral of patients with symptoms of colorectal disease but at low risk of cancer It is recommended that in patients having a normal abdominal and rectal examination and haemoglobin estimation that the following symptoms be used to identify patients at very low risk of bowel cancer: Rectal bleeding with anal symptoms (itching, discomfort, soreness, lump, prolapse, and pain) Transient changes in bowel habit particularly to harder stools and/or decreased frequency of defecation Abdominal pain as a single symptom without other high risk symptoms or signs, an iron deficiency anaemia or intestinal obstruction Weight loss in the absence of high risk symptoms unless it is rapid and profound Patients with these symptoms can be safely managed initially in primary care by careful treat, watch and wait strategies and reviewed in no longer than eight weeks. If symptoms persist off all treatment then If they remain low risk refer routinely using Choose & Book If they remain in low risk category but are worrying/severe refer using Choose and Book If they change to higher risk refer urgently Rapid access General Practitioners are encouraged to refer patients with a high index of suspicion of cancer as a matter of urgency using the 2WW system High index of suspicion of cancer Patients of Any Age: A definite palpable right sided mass Rectal bleeding with change of bowel habit persistent for 6 weeks (in patients aged 40 years) Unexplained iron deficiency anaemia (Hb<11g/dl in men or 10g/dl in post menopausal women) A suspicious lower gut investigation (sigmoidoscopy, colonoscopy, barium enema) Palpable rectal mass (not pelvic) Patients 60 years: Rectal bleeding persistently without anal symptoms for 6 weeks Change of bowel habit to looser stools and/or increased frequency of defecation without rectal bleeding and persistent for 6 weeks General Practitioners should provide information on: Family history (including first and second degree relatives with cancer, FAP, HNPCC) 5

6 History of GI Disease Current medication The results of recent investigations in particular FBC, U and E, endoscopy, barium studies Criteria summary Rectal bleeding with a change in bowel habit to looser stools and/or 40+ increased frequency of defecation persistent for 6 weeks Change in bowel habit as above without rectal bleeding and persistent 60+ for 6 weeks Rectal bleeding persistently without anal symptoms* 60+ A definite palpable right-sided abdominal mass A definite palpable rectal mass (not pelvic) All ages Unexplained iron deficiency anaemia below 11 g/dl in men below 10 g/dl in women(non-menstruating) *Anal symptoms include soreness, discomfort, itching, lumps and prolapse as well as pain. These items are incorporated into the Primary Care Referral Proforma for each Colorectal Cancer MDT so that this part of the referral process is uniform across EMCN. General Practitioners are encouraged to make referrals using the appropriate referral proforma. General Practitioners are actively discouraged from requesting barium enemas where there is a high index of suspicion of cancer. It has been agreed that endoscopy is the preferred diagnostic modality Other risk factors In patients with ulcerative colitis, a plan for follow-up should be agreed with a specialist and offered to the patient as a normal procedure in an effort to detect colorectal cancer in this high-risk group. There is insufficient evidence to suggest that a positive family history of colorectal cancer can be used as a criterion to assist in the decision about referral of a symptomatic patient Screening policy (co-ordinating lead author Mr Julian Williams) Patients identified as having colorectal cancer through the NHS Bowel Cancer Screening Programme should be informed of the diagnosis and counselled by the Specialist Screening Nurse. The Specialist Screening Nurse should refer, within 48 hours, for appropriate staging and discussion at the local Colorectal Cancer MDT meeting Evaluation of referrals Choose and Book Referrals for patients with large bowel problems will be evaluated in accordance with the Trust escalation policy (usually by a surgeon or gastroenterologist who is a member of a Colorectal Cancer MDT) and if there is cause for concern the 6

7 urgency of the referral will be raised and the patient booked accordingly. Patients will be notified in accordance with the relevant Trust policy. Emergency referrals Emergency referrals: within normal working hours Patients who present as emergencies within normal working hours should as far as possible be managed by designated Colorectal Cancer MDT members Emergency referrals: outside normal working hours Patients who present as an emergency outside of normal working hours should, where possible, be managed by designated Colorectal Cancer MDT members. In all cases, the expectation is as follows: Where possible patients presenting as an emergency, both within and out-ofhours, to non-members of the Colorectal Cancer MDT should have their condition stabilised then be passed to the surgical core members of the Colorectal Cancer MDT for discussion of their further care. This should be by the end of the first working day after presentation However if further delay would be life threatening then non-core members of the Colorectal Cancer MDT should proceed to the treatment that is required to ensure the patient s safety The responsibility for referral to the Colorectal Cancer MDT core member rests with the receiving surgeon The methods of contact are compliant with the policy of the individual Trusts and include: direct by telephone to consultant or PA by fax with clearly marked priority person to person contact 7

8 Obstruction Resuscitate and Stabilise Perforation or Bleeding Resuscitate and Stabilise CT Scan +/- contrast enema Other investigation as necessary Bowel/caecum in danger of perforation Bowel/caecum not in danger Surgery Surgery/stent Refer with in one working day to a core member of the MDT Discuss with Core Member of the MDT Discuss with core member of the MDT Surgery/stent MDT Onward referral between teams (co-ordinating lead author Mr Adam Scott) The Colorectal Cancer MDTs all provide the diagnostic work up within the EMSCN and are of sufficient size and have sufficient resources to manage routine and emergency patients with primary colorectal carcinoma. Such patients are, therefore, normally treated locally within the MDT service. Thus handover from standalone diagnostic services does not apply The algorithm for incidental finding responsibilities is in Appendix Referral guidelines and assessment protocol for early stage rectal cancer Those patients with a suitable Stage T1 rectal cancer (T1 are those patients selected for local resection by the Network assessment protocol for early cancer). Local resection, for the purposes of peer review, is defined as a resection procedure intended to achieve complete local removal of malignant disease from the primary site 8

9 but does not involve the resection of the full circumference of the bowel and removal of a complete segment. Patients with invasive rectal cancers for whom surgery is being considered should have Magnetic Resonance Imaging (MRI) scans before treatment begins, in order to determine the precise location and extent of the tumour and clarify who might benefit from neoadjuvant therapy and who is likely to be adequately treated by surgery alone. Some patients with T1 tumours may benefit from local excision and should be referred to a surgeon with appropriate expertise within the network. Guidance on the treatment of early rectal cancer is provided below (please see section 14) Referral guidelines for anal cancer Anal cancer is a rare disease and specific expertise is important to optimise outcomes for patients. In the past few years, chemo-radiotherapy has become the treatment of choice for these tumours and trials suggest there is a 60%+ sphincter preserving rate with such treatment with similar or better local control and survival compared to surgery. It is important to note that some co-existing medical diseases may render chemo-radiation inappropriate e.g. active ulcerative colitis, Crohn s disease, poor peripheral circulation. Such co-morbidities will enhance the toxicity of combined treatment due to reduced tissue tolerance. All patients with anal cancer should be discussed initially in the local colorectal MDT and then referred to the relevant designated anal cancer MDT: East Midlands South East Midlands North The two anal cancer MDTs will discuss cases of anal cancer and where possible oncological treatment will be delivered at a local centre (Leicester, Northampton, Derby, Lincoln and Nottingham). Surgical treatment should be infrequent and should be under the care of one of the core surgical members, with the support of plastic surgery, and gynaecology where needed. Patients presenting with faecal incontinence from tumour damage to sphincters will be considered for surgery. Referral details to include accurate description of the lesion including: size position and whether anal margin or anal canal proper relationship to the sphincter complex All these patients should have staging investigations including MRI/CT scan of the abdomen, pelvis and inguinal nodes in their local referral centre. Patients with confirmed squamous cell carcinoma of the anus do not require a full colonoscopic examination. 9

10 Patients with residual or recurrent disease following chemoradiotherapy requiring salvage surgery should be referred to the anal cancer MDT. This surgery should be performed under the EMSCN designated specialist surgeon in centres with plastic surgery input. The clinical responsibilities for the patient along the pathway are as follows: Stage of the patient pathway Patient referred: 2 week wait Choose and Book/non-cancer referral Diagnostic investigations Referred to Colorectal MDT Staging and work up for diagnosis of anal cancer Anal Cancer MDT Primary Chemoradiation on protocol Follow-up Salvage Surgery Responsible clinician General Practitioner General Practitioner (investigative consultant should alert the MDT) Surgeon (close information sharing with the General Practitioner) Colorectal MDT Patient discussed at next Anal Cancer MDT in parallel with the treatment pathway Anal Cancer Lead Anal Cancer MDT Oncologist at UHL/NUH/Royal Derby Hospital/NGH and ULHT Colorectal MDT Anal Cancer MDT Guidance on the treatment of anal cancer is provided below (please see section 13) Referral guidelines for liver metastases Each Colorectal Cancer MDT uses the network agreed protocol for referral of patients with liver metastases to a Hepatobiliary MDT for assessment. All patients with liver metastases who have had radical treatment of the primary colorectal cancer are potential candidates for liver resection The referral is made using the agreed local operational process.. Patients with extrahepatic metastases should still be considered for liver resection if they have single site extrahepatic disease. Guidance on the treatment of liver metastases is provided below (please see section 15) Referral guidelines for lung metastases Each Colorectal Cancer MDT will use the network agreed protocol for referral of patients with lung metastases to a Lung MDT for assessment. An initial assessment should be undertaken by the Colorectal Cancer MDT. The decision to proceed to 10

11 metastatectomy should be made by the Lung MDT. Guidance on the treatment of lung metastases is provided below (please see section 16) Referral policy for urological and gynaecological complications Each Colorectal Cancer MDT will have local arrangements with urological and gynaecological surgeons for the joint management of appropriate patients Referral policy for unexpected diagnosis of colorectal cancer by clinicians who are not members of the colorectal cancer MDT There are instances when patients are diagnosed unexpectedly or incidentally with colorectal cancer, or known patients are diagnosed with recurrent or metastatic disease by clinicians who are not members of the Colorectal Cancer MDT. When this occurs the clinician should refer the patient to a named core member of the local Colorectal Cancer MDT or, if appropriate, the MDT that previously managed the patient. The referral should be made as soon as is practicable and should be no later than the end of the first complete working day following diagnosis. It is the responsibility of the referring consultant to ensure that the appropriate MDT member receives the referral. The referring consultant will also need to explain to the patient why they are referring to another consultant and should also advise the GP of the referral Incidental presentations of bowel cancer Following discovery of a colorectal carcinoma in the course of investigation by a non-colorectal team (either as a routine outpatient or as a non-cancer emergency) the patient should be referred to a named surgical member of the local Colorectal Cancer MDT at the earliest opportunity. Such referral should occur by the end of the first working day to ensure delay is minimised. The consultant responsible for the care of the patient at the time the diagnosis is made is the individual responsible for making the appropriate referral. Following direct access to endoscopy the consultant responsible for the endoscopy list (even if the endoscopy is carried out by a junior doctor or nurse endoscopist) is responsible for ensuring that where appropriate investigation pathways are commenced immediately (if the tumour is clinically likely to be a carcinoma) Following discovery of a colorectal carcinoma in the course of investigations by a non-colorectal team the patient should be referred to the Colorectal Cancer MDT. Following discussion the patient may be accepted under the care of one of the members which could be a surgeon, oncologist or palliative care physician for instance. Such referral should occur by the end of the first working day to enable the patient to be discussed at the next available Colorectal Cancer MDT and to ensure the minimum of delay. 11

12 Following direct access to endoscopy the consultant responsible for the endoscopy list (even if the endoscopy is carried out by a junior doctor or nurse Endoscopist) should be responsible for ensuring that where appropriate investigation pathways are immediately commenced, (if the tumour is clinically likely to be carcinoma) and that the patient is discussed at the next appropriate Colorectal Cancer MDT. This may depend on the timing of the meeting relative to biopsy results being available etc. It is recognised that the consultant in charge of the list does not automatically take over full care of the patient but is responsible for ensuring the patient is allocated to an appropriate member of the Colorectal Cancer MDT. It is possible that the GP after discussion with the patient may opt to refer to a different service but this possibility should not delay commencing the patient pathway in the first instance. Following discovery of a metastasis of colorectal origin by another MDT a member of the other MDT should either: present the patient to the Colorectal Cancer MDT so a decision in respect of further investigation can be made, or if that is not practical, ensure a formal referral to a Colorectal Cancer MDT member who can present the case at the next Colorectal Cancer MDT. The above Secondary to Secondary guidelines have been distributed to the EMSCN Colorectal, Upper GI surgeons, gynaecologists, gastroenterologists, consultant physicians, care of the elderly physicians and cancer imaging consultants through the Trust internal processes. 5.0 Investigation policies for bowel cancer See the Bowel Cancer Pathway algorithm at the front of the guidelines. 5.1 Imaging guidelines (co-ordinating lead author Dr Neil Fairlie) These guidelines are based on: Royal College of Radiologists: Recommendations for Cross Sectional Imaging in Cancer Management (2006) Association of Coloproctology of Great Britain & Ireland: Guidelines for the Management of Colorectal Cancer (2007) UK PET CT Advisory Board Guidance ( January 2009) Imaging in colorectal staging and follow-up Initial diagnosis in patients presenting with symptoms suggestive of colonic malignancy Endoscopy (for those fit and able to tolerate bowel cleansing) CT colonography (for the less mobile) (can they climb a flight of stairs?) or when endoscopy is incomplete. 12

13 Unprepared colon CT (for the very infirm and those unable to tolerate bowel cleansing). Barium enema currently not in widespread use but may have a role in selected circumstances Staging of patients presenting with malignancy diagnosed on endoscopy and who are suitable for surgery rather than palliation Rectal tumour Initial diagnosis 1 whole abdomen, chest and pelvis should be imaged this is likely to be with MRI pelvis and CT chest and liver with intravenous (iv) contrast. ERUS of rectum for those patients suspected of having a T1 tumour After chemo-radiotherapy and before surgery - CT scan of chest, abdomen and pelvis with iv contrast +/- MR pelvis. Follow up scans (minimum after 2 years 2 ; suggested frequency after 18 months, 3 and 5 years) CT scan of chest and liver with iv enhancement Colonic tumour proximal to rectum Initial diagnosis - CT of chest and liver with iv contrast enhancement Follow up scans (minimum after 2 years; suggested frequency: 1 year, 3 and 5 years) CT scan of chest and liver with iv enhancement. This will be influenced by the FACS trial results***. All patients with colonic malignancy who are fit for surgery should have colonoscopy at diagnosis or within 6 weeks of emergency surgery and then every 5 years providing they are still fit for further treatment. If colonoscopy is incomplete patients should be offered CT colonography. Patients with renal impairment or iv contrast allergy should have alternative liver imaging such as ultrasound or MRI in addition to unenhanced CT of the lungs and abdomen PET - CT in colorectal malignancy Apart from the demonstration of an incidental tumour on a PET-CT scan performed for staging or follow up of a non-colorectal malignancy, PET-CT should play no part in the initial diagnosis of colorectal malignancy. PET-CT should be considered for the assessment of a mass at the site of a treated tumour to differentiate between fibrosis and residual or recurrent 1 Recommendations for Cross-Sectional Imaging in cancer management CT, MRI and PETCT RCR August

14 tumour. Such a PET-CT scan should ideally be performed at least 18 months after surgery. PET-CT is useful in the assessment for suitability for surgery of colorectal metastases in liver or lung (please see separate documentation). (The UK PETCT Advisory Board Guideline 2 states: Colorectal cancer: Patients considered for radical treatment with a prior history of colorectal cancer and proven or suspected disease relapse, and patients with synchrnous metastases at presentation potentially suitable for resection. Indicated volume 40-80/million population.) Staging Liver CT Additional MRI/US if higher resolution required Lungs CT Blood tests Haemoglobin Electrolytes, urea and creatinine Liver function tests 5.2 Histopathology guidelines and standards (co-ordinating lead author Dr Steve Milkins) General principles A designated Histopathologist or deputy should attend the Colorectal Cancer MDT meetings. Histological proof of invasive carcinoma for all rectal and anal tumours is required. Histological proof of invasive carcinoma for colonic tumours should be obtained where possible. Colorectal cancer resections should be reported according to the Royal College of Pathologist Dataset for Colorectal Cancer (Appendix 2). Additional data items may be included by local agreement. Laboratories involved in the investigation and diagnosis of patients with, or suspected to have, colorectal cancer should participate in appropriate external accreditation such as CPA (UK) and external quality assessment schemes e.g. East Midlands Histopathology EQA. 2 UK PETCT Advisory Board Final Version January 2009 Oncology FDG PET CT scan referral criteria 14

15 Histopathologists should take part in appropriate regional or national external quality assessment schemes, either specialist or including colorectal pathology Guidelines for the examination and reporting of colorectal cancer specimens Introduction These guidelines for the examination and reporting of colorectal cancer specimens are based on the following national guidance: The dataset for colorectal cancer histopathology reports issued by the Royal College of Pathologists. UKCCCR Handbook for the Clinico-Pathological Assessment and Staging of Colorectal Cancer. NICE guidance on cancer services: improving outcomes in colorectal cancers (May 2004). NHS BCSP Publication No 1. Reporting lesions in the NHS Bowel Cancer Screening Programme Colorectal cancer reports should normally be reviewed by the lead histopathologist for the local Colorectal Cancer MDT prior to the Colorectal Cancer MDT meeting. All histopathologists reporting colorectal cancer should adhere to Colorectal Cancer MDT guidelines and participate in appropriate EQA and audit. Where any doubt exists regarding diagnosis or staging, a second consultant with an interest in colorectal cancer should review the specimen. Biopsies and resections should be reported within an agreed local time frame in order to facilitate appropriate clinical decision making at the Colorectal Cancer MDT meeting Specimens and specimen examination Diagnostic Colonic and rectal biopsies Needle core biopsies (abdominal masses or liver metastases) Laparoscopic biopsies and peritoneal cytology (including clots) samples to determine peritoneal involvement Therapeutic Colectomy including laparoscopic procedures Anterior resection ± total mesorectal excision (TME) Abdomino-perineal excision of rectum (APER) ± TME Extralevator APER Trans-anal resection of tumour (TART) Transanal endoscopic micro surgery (TEMS) Snare polypectomy 15

16 Endoscopic mucosal resection (EMR) Specimen examination Specimens should be examined according to a defined protocol within each histopathology department. These protocols should be regularly reviewed and updated by the lead colorectal histopathologist, in consultation with colleagues Dataset for reporting colorectal cancer Biopsies Request clinical data must include endoscopic appearances exact site and nature of biopsy and other clinically relevant factors e.g. other malignancies. Reports should include as minimum detail: Tumour type Tumour grade Further procedures e.g. Immunocytochemistry may be required if there is a possibility of local spread from another site e.g. ovary or metastatic disease Resections The clinical details must include exact site and type of operation. Full clinical data including whether procedure is laparoscopic and the details of any preceding neoadjuvant treatment or prior surgery. The Royal College of Pathologist s dataset should be incorporated into reports. Departments should be using Version 2 of the dataset or at least have a mechanism for ensuring the additional dataset items and modification to the T staging relating to perforation and serosal involvement are included. Additional data items e.g. anterior quadrant involvement can be included by local agreement, provided that all of the minimum dataset items are included The RCPath Dataset is available at Departments and Colorectal Cancer MDTs should work towards recording and storing the dataset as individually categorised items in a database. This will facilitate electronic retrieval for data collection, research and audit. As a minimum the report should have a well-designed section of text so that key items can be easily located during Colorectal Cancer MDT discussion and if no electronic method exists will facilitate entry of data into a database Grading and staging conventions Tumour grading WHO invasive carcinoma grading system Tumour staging 16

17 TNM classification (5 th edition) Dukes stage Use of ancillary laboratory techniques A large majority of colorectal cancer specimens require only routine staining. However, laboratories should have available appropriate immunohistochemical procedures for the following: Suggested histogenesis of intra-abdominal tumour of unknown origin Suggested histogenesis of poorly differentiated colorectal tumours Presence or absence of neuro-endocrine differentiation Phenotyping of spindle cell tumours Where appropriate Oncologist may need extended ras assessment to determine suitability for monoclonal chemotherapy. Background normal bowel should be included in case subsequent genetic studies are needed for patient care Audit All histopathologists involved in the reporting of colorectal cancer should participate in a relevant EQA scheme and local audit. Audits might include: compliance with minimum datasets timeliness of reporting logging of diagnostic discrepancies identified during review In addition to RCPath Dataset recommends three standards that should be audited regularly Mean lymph node harvest of 12 Serosal involvement 20% for colonic cancers and 10% for rectal cases Extramural invasion detection of at least 25% Completion with these audit will also validate the level at which the standard should be set nationally Polyp cancers Whether or not these are generated from the Bowel cancer screening programme these should be reported using the RCPath Colorectal Polyp Cancer dataset Referral for review or specialist opinion Bowel cancer screening programme cases Within a screening centre territory if a cancer is to be treated outside the colonoscopy centre Colorectal Cancer MDT then the original lab should double report a diagnostic biopsy but these would not normally require to be seen at the operating centre. If there is any particular difficulty e.g. a superficial biopsy with equivocal invasion or a lesion that clinically was unsuspected the biopsy should be sent to the operating Colorectal Cancer MDT or be directly discussed with the histopathologist at that centre so they can fully appreciate the features of the case. 17

18 Referral for treatment from outside the EMSCN The histopathology reports for patients referred for treatment to a hospital within the East Midlands should be discussed by the local Colorectal Cancer MDT and, where appropriate, the sections should be reviewed by the Lead Histopathologist Referral for specialist opinion In most cases the diagnosis of colorectal cancer is relatively straightforward. However, in cases of diagnostic difficulty a specialist opinion should be sought from an appropriate expert histopathologist. The bowel screening programme has a defined expert panel which is funded by the BCSP. In accordance with CPA standards each laboratory should have a defined protocol for gaining external opinions. 6.0 Flow of clinical responsibilities Stage of Clinical Care Responsible Clinician(s) Prior to First appointment with General Practitioner Secondary care Diagnostic Stage OP appointment attended. General Practitioner Initial Treatment Phase Surgeon (Colorectal Cancer MDT) Primary Surgery Assuming surgical intervention Surgery Surgeon accepting responsibility at the Colorectal Cancer MDT in the first instance. Primary non-surgical Radiation and or Chemotherapy, Clinical/Medical Oncologist oncological intervention during this phase the consultant oncologist accepting the patient referred at the Colorectal Cancer MDT until this phase concluded and the patient passed back to the Surgeon. Post surgery If Oncology treatment subsequently required during active treatment the consultant oncologist Clinical/Medical Oncologist Treatment for metastatic disease Follow up Palliative Care For this phase the clinical applying the modality e.g. Thoracic surgeon, Oncologist. Will depend on the treatments given. Normally the Consultant Surgeon. General non-complex palliative care is usually provided by patient s GP and primary care team. Patients with complex/unresponsive needs should be referred to the Specialist Palliative Care Service. Clinician in the relevant treatment modality Surgeon GP/Specialist Palliative Care Team General Principles All through the patient pathway there should be ongoing access to the Clinical Nurse Specialists and Colorectal Cancer MDT. Supportive and Palliative Care should be provided as an integral part of the patient s management by all health professionals involved (see section 9). Timely, detailed communication with patient 18

19 and Primary Care colleagues is essential. Decisions can be made determining the care of the patient within a single modality by the responsible clinician. Decisions concerning modalities not covered by the currently responsible clinician should be referred back to an MDT for wider discussion. Acquiring status of responsible clinician is an active event. For endoscopy initial events the consultant responsible for the list must ensure that the patient is entered for the next Colorectal Cancer MDT and that if they are not going to provide the next stage that the patient has been accepted by another clinician. This policy should not inhibit referral for support from other clinician, e.g. Palliative radiotherapy. 7.0 Surgical treatment guidelines (co-ordinating lead author Mr Saleem El- Rabaa) Waiting times Treatment should begin within 31 days of a decision to treat, this should be within 62 days of referral, unless the patients is 1. unfit for surgery 2. refusing surgery MDT 1. All patients are discussed at the MDT prior to surgery unless emergency intervention is necessary. 2. The role of the MDT is to provide the patient with an informed surgical opinion regarding their management and receive the necessary support from the time of their cancer diagnosis. Surgical specialisation Surgeons involved require the appropriate training (members of specialist groups, formally accredited) or having extensive experience and must work as part of the MDT Informed consent Must be obtained: A period of time where questions can be asked and information reiterated is important. Wherever possible consent should be obtained by the operating surgeon. An information leaflet (operation specific) should be available to all patients. Stoma preparation Preoperative contact with the stoma team (as early as possible), along with preoperative site marking should be organised Group and save Of blood should be undertaken, cross matching can be prepared within ½ an hour 19

20 Bowel Preparation Should NOT be routine Thromboprophylaxis All Patients should routinely have thromboprophylaxis, with TEDS and low molecular weight heparin(lmwh) according to DVT risk assessment. Antibiotic prophylaxis Should also be routine (depending on local hospital policy and patient s allergy history). Wound infection rates should be less than 10% and should be included in the Trust s regular audit cycle. Enhanced Recovery Programme Programmes are now either commissioned or currently under development in most Network hospitals. All appropriate patients are enrolled within the programme to improve quality of care and to reduce the inpatient stay. Curative resection(open or laparoscopic) Should be based on surgical and histological evidence of complete excision. Surgeons should expect to achieve an overall curative resection rate of more 60% but it is appreciated that this will depend at least in part on the stage at which the patients present. A rectal tumour Is defined as any tumour whose distal margin is seen at 15cm or less from the anal verge using rigid sigmoidoscopy. This definition is based on the fact that rectal cancer treatment differs from colonic cancer especially in regard to radiotherapy. Resection 1. It is recommended that total mesorectal excision should be performed for tumours in the lower 2/3 of the rectum either as part of a low anterior resection or abdomino perineal excision (APER) in order to achieve 5 cm of lymph node clearance. 2. In tumours of the upper 1/3 of the mesorectum should be divided no less than 5 cm below the lower margin of the tumour 3. Damage to pelvic autonomic nerves and plexuses should be avoided as well as tumour perforation. 4. Extended right hemi colectomy is preferred to segmental resection of transverse colon Anastomosis 20

21 1. Stapled anastomosis is standard now in all laparoscopic and open rectal surgery, and eliminate individual variation in leak rate, and facilitate ultra low pelvic anastomsis. 2. Hand sewn interrupted seromucosal stitching has the lowest reported leak rate. Anastomosis type in open surgery depends on surgeon choice 3. Anastomotic leakage has poor survival and is associated with an increase in recurrence rate. 4. Cytocidal washout of rectal stump prior to anastomsis is advised 5. Leak rate should be carefully audited with rate of <8% for anterior resection and <4% for all other types of resection 6. Operative mortality of less than 20% for emergency surgery and <7% for elective surgery for colorectal cancer 7. Temporary defunctioning stomas are recommended as well as consideration of colonic pouches (in order to reduce frequency of stool following low anterior resections) Stoma formation Has no ideal ratio however the recommendation is that of the overall proportion of resectable RECTAL cancers treated with APER should be less that 30%, if 1cm of clearance can be achieved, plan for anterior resection, if in doubt second opinion should be sought Local excision Only pt1 cancers that are well/moderately well differentiated and less than 3cm in diameter are suitable for local excision, if histology is worse than expected MRI and further treatment are likely to be needed. Transanal endoscopic microsurgery appears to be just as good as transanal resection and may even be beneficial with middle 1/3 rectal tumours. Other indications maybe if the patient is unfit for surgery or as part of a clinical trial. Record keeping Should meet Royal College of Surgeons guidelines (1990) and check lists are advocated in order to construct the operation note. Emergency cases The outcome is less attractive, preoperative CT in the obstructed patient is advised (to rule out pseudo obstruction). Only life threatening bleeding requires emergency surgery, otherwise urgent resection following optimisation is advised. Ileocolic anastomsis for right sided tumours, defunctioning for left sided unless conditions are favourable and primary anastomsis can then be attempted. Surgery during the daytime by MDT members is desirable and mortality in the emergency/urgent group should not exceed 25%. Stenting is a valid option for large bowel obstructing tumours, both as a palliative measure or as a bridge to surgery. 7.1 Preparation for surgery (in line with the Local Operational Policies) 21

22 This will include: Informed consent Cross-matching Preparation as part of Enhanced Recovery where in place Thrombo-embolism prophylaxis Antibacterial prophylaxis Provision of stoma information 7.2 Specific aims of surgery for rectal tumours Total mesorectal excision for middle and lower third tumours for potentially curative patients Division of mesorectum at least 5cm beyond upper rectal tumours Preservation of the pelvic autonomic plexus Sphincter preservation where possible Trans anal endoscopic surgery in suitable patients with T1 tumours 7.3 Laparoscopic surgery policy (co-ordinating lead author Mr Krishnamurthy Badrinath) Laparoscopically assisted surgery is oncologically equivalent to open surgery with the advantage of earlier and better quality post-operative recovery. Laparoscopically assisted surgery for colorectal cancer should be offered to suitable patients by appropriately trained members of the Colorectal Cancer MDT. All patients considered suitable should be offered laparoscopic colorectal cancer surgery. Relative contra-indications include: Very high BMI Obvious T4 cancers on preoperative staging if circumferential margin is likely to be compromised Clinical or radiological signs of obstruction Surgery will in the final analysis be at the clinical discretion of the surgeon operating after full discussion with the patient. To ensure wider provision of this service, Colorectal Cancer MDTs should enable interested surgeons to undergo appropriate training through LAPCO (national training programme for laparoscopic colorectal surgery). Category NBOCAP EMCN NSSG definition 1 Open 2 Laparoscopic then open 3 Laparoscopic converted to open Initial laparoscopic assessment, followed by open mobilisation and anastomosis Incision larger than that required to remove specimen either due to failure to complete mobilization or complications that cannot be dealt with laparoscopically 22

23 Category NBOCAP EMCN NSSG definition 4 Laparoscopic completed Incision only as large as required to remove specimen and to include 1) right and extended right hemicolectomy where mobilization is completed laparoscopically and anastomosis performed extra corporeally. 2) A Pfannensteil incision to complete a rectal resection. In patients requiring conversion, it usually happens soon after initial laparoscopic assessment, and this probably accurately reflects NBOCAP category 2. A conversion to open after a significant part of the operation is done laparoscopically is probably due to a complication/lack of progress and can be recorded in the category 3 of the above table. It is expected that there will be routine audit of: Number of lymph nodes retrieved Quality of mesorectum Leak rates Stoma rates Hand-assisted laparoscopic surgery (HALS) Laparoscopic colorectal surgery in the obese The authorised personnel to perform laparoscopic colorectal cancer surgery throughout EMSCN are to be found in the Constitution. 7.4 Emergency surgery The guidelines below apply within and outside of normal working hours In some cases with life threatening conditions (as specified in the manual of colorectal measures) emergency surgery may, by necessity, be undertaken by surgeons who are not members of the Colorectal Cancer MDT In the absence of perforation or life threatening bleeding the patient should be stabilised and referred by the emergency team to a colorectal surgeon by the end of the first working day, if practicable. Wherever possible preparation for surgery should be completed as indicated and in all cases antibiotic and DVT prophylaxis should be administered. There are no hospitals within the EMSCN without a Colorectal MDT. The above guidelines on the management of surgical emergencies related to colorectal cancer have been distributed to the EMSCN Colorectal, Upper GI and Gynaecology ECAGs and shared with Trust Cancer Managers for distribution to surgeons and physicians on the surgical/medical emergency take rotas. 7.5 Bowel preparation (co-ordinating lead author Mr Saleem El-Rabaa) 23

24 The debate and controversy has not yet settled, between mechanical bowel preparation, and no mechanical bowel preparation in elective colonic bowel resection. However, there are no statistically significant differences when comparing the outcomes of the two groups of patients in terms of leakage at the surgical join of the bowel, mortality rates, peritonitis, need for reoperation, wound infection, and other non-abdominal complications. Consequently, there is no evidence that mechanical bowel preparation improves the outcome for patients. Further research on mechanical bowel preparation versus no preparation in patients submitted for elective colorectal surgery is warranted. (GuenagaKKFG, MatosD, Wille-Jørgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD DOI: / CD pub3) There is good evidence to suggest that mechanical bowel preparation using polyethylene glycol (PEG) should not be used before elective colorectal surgery (Slim 2004 Ia). In addition, bowel preparation with a phosphate enema was associated with an increased risk of anastomotic leakage requiring re-operation, compared with oral PEG (Platell 2006 Ib). A randomised trial of sodium picosulphate (Picolax) versus no preparation showed that bowel preparation did not influence outcome after colorectal surgery (Burke b). In all the studies which reported details of those with anastomotic leak, incidence was most common in those undergoing anterior resection and low anterior resection. Absence or presence of defunctioning stoma and pre-operative radiotherapy influence the severity and risk of leak in this patient group. The rationale for avoiding bowel preparation prior to low anterior resection is less compelling than for colonic resection. (Unless colon very loaded) Low anterior defunctioning procedures should probably have bowel preparation. The introduction of Enhanced Recovery Protocol and laparoscopic colonic resection seems to tip the balance towards no mechanical bowel preparation. In summary the bowel preparation is left to the clinician discretion. Guideline for bowel preparation (for discussion) Right colonic lesion No Bowel preparation is needed Left colonic lesion Low residue diet +/- phosphate enema Rectal lesion Low residue diet +/- phosphate enema 24

25 7.6 Treatment of bowel cancer screening detected polyp cancers If Invasive adenocarcinoma in polyp following colonic polypectomy, TART or TEM then: INVASIVE ADENOCARCINOMA IN POLYP (Colonoscopic polpypectomy, TART or TEM) Poorly differentiated? NO Excision complete? i.e. 2mm margin YES Prominent submucosal invasion present? Or definite invasion near muscularis propria if muscularis propria in specimen (equivalent to Kikuchi level sm3) YES NO YES Surgery NO Colonoscopic Follow Up As Per Agreed Protocol 7.7 Documentation Operation notes should adhere to guidelines issued in the RCS Guidelines for Management of Colorectal Cancer June Non surgical oncology (co-ordinating lead author Prof Will Steward) 8.1 Chemotherapy The Oncologists, EMSCN Pharmacists and Chair of the EMSCN Network Chemotherapy Group have agreed the following Chemotherapy Algorithms and Regimens for Colorectal Cancer:- Adjuvant Colorectal Chemotherapy Algorithm Neoadjuvant Colorectal Algorithm Metastatic Colorectal Chemotherapy Algorithm Colorectal Cancer Chemotherapy Regimens Please follow this link to view it on the EMSCN website for further details: 25

26 Oncology-Colorectal.aspx Chemotherapy agents require special care in delivery and dealing with adverse effects. There should be written protocols on the management of complications and toxicities. Chemotherapy should be given in accordance with JCCO guidelines 4 and according to protocol guidelines on the EMCN website. Patients receiving chemotherapy should have access to emergency care, and both patients and GPs should have access to information and advice from Oncology trained staff on a 24 hour basis. They should be given written information on appropriate action for dealing with side effects of chemotherapy Adjuvant chemotherapy Dukes stage C disease All patients should be considered for adjuvant chemotherapy. This confers a significant survival benefit Dukes stage B disease The benefits of adjuvant chemotherapy for Dukes B disease are less than those for stage C. Dukes B patients should be tested for mismatch repair gene status (MMR) status and considered for chemotherapy if proficient in MMR. Chemotherapy is not recommended for patients with Dukes A disease and should not routinely be given to patients with resected rectal cancer as there is little, if any, benefit in terms of improved long term survival. There may be some patients with advanced Dukes C rectal cancer for whom adjuvant chemotherapy is considered but these must be informed about the very small chance of benefit (if any) and potential risks of toxicity Chemotherapy for advanced disease Potentially resectable liver metastases For patients who are found to have liver metastases, there is the increasing potential with new ablative and resection techniques to offer a proportion of patients the chance of cure. If disease is resectable, approximately 30% of patients will have long term survival with the addition of chemotherapy. Recent evidence has suggested that preoperative chemotherapy can convert patients who have liver-only disease into a stage where resection is technically appropriate. Please see Chemotherapy-Oncology-Colorectal.aspx for regimens Non resectable disease 26