NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for Clinical Practice

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1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for Clinical Practice Review of Cancer Service Guidance: Colorectal Background information Guidance issue date: 1997 (by NHS Executive) Guidance updated: 2004 (by NICE) Review of 2 sections within the guidance (focusing on the organisation and management of services for early rectal cancer specifically multi disciplinary teams (MDTs) and arrangement of services for the management of bowel obstruction caused by colon cancer) within the Improving outcomes in colorectal cancers service guidance. Review recommendation The sections of the colorectal cancer service guidance relating to organisation and management of services for early rectal cancer and arrangement of services for the management of bowel obstruction caused by colon cancer should be considered for an update. The close interface with clinical management suggests this update should be considered in the context of a potential review and update of the clinical guideline on colorectal cancer (CG131) c Factors influencing the decision Process for reviewing the guidance 1. Following discussion between the Director of the Centre for Clinical Practice and the National Clinical Director for Cancer it was agreed that two aspects of the Improving Outcomes Guidance for Colorectal Cancer (relating to service delivery aspects of early rectal cancer multi- 1 of 29

2 disciplinary teams (MDT) and for the management of emergency bowel obstruction due to colon cancer) should be reviewed. 2. Current epidemiological data was obtained from the National Cancer Intelligence Network and the Office for National Statistics (ONS) and is summarised below along with initial intelligence gathering, qualitative feedback from the Centre for Clinical Practice Director and an expert focus group (comprising of gastroenterologists, pathologists, colorectal surgeons and medical oncologists), post-publication enquiries, implementation feedback and relevant studies identified through focused literature searches. Epidemiology 3. Current epidemiological data was obtained and compared with the data presented in the Improving outcomes in urological cancers service guidance. Data from the ONS indicated in 2010 there were 33,218 new cases of colorectal cancer with 18,590 new cases in men and 14,628 in women in England. Just under two thirds of patients were diagnosed with colon cancer, nearly one-third with rectal cancer, and the remaining 5% of patients with rectosigmoid cancer. 4. Age standardised incidence rates for colorectal cancer have increased by 33% for men and 14% for women between 1971 and 2009 in England. Rates peaked at 58 cases per 100,000 in men in For women, rates peaked at 38 cases per 100,000 women in 1992 and However, overall the colorectal cancer incidence rates have remained relatively stable over the last decade. Colon and rectal cancer incidence in the UK shows very little geographical variation. 5. Rectal cancer patients are more likely to have a cancer that is confined to the wall of the bowel (25%) than colon cancer patients (13%) with some indication that these numbers may be rising. 6. Colorectal cancer in England had a mortality rate of 21 deaths per 100,000 for men and 13 per 100,000 for women in Age 2 of 29

3 standardised mortality rates for colorectal cancer have halved for women between 1971 and 2010 and have decreased by 38% for men. 7. Five year survival rates are increasing for colon cancer, with 54% for men and 55% for women diagnosed in and followed up to Ten-year survival rates are only a little lower than those at fiveyears indicating that most patients who survive for five years are cured from this disease. For cancer of the rectum, five-year survival was 55% for men and 57% for women diagnosed in and followed up to Survival rate is dependent on the stage of disease at diagnosis. 93.2% of patients diagnosed with the earliest stage of disease (Dukes A) survived five-years from diagnosis compared to only 6.6% of those with advanced disease which has spread to other parts of the body at diagnosis (Dukes D). Currently only around 13% of colorectal patients are diagnosed with a Dukes A cancer. Literature search 9. From initial intelligence gathering and qualitative feedback from the NICE Centre for Clinical Practice Centre Director, focused literature searches were conducted for the following clinical areas: Early rectal cancer MDTs o What is the best model for organising care for patients with early rectal cancer with regards to decision-making and the delivery of minimally interventionist care Emergency bowel obstruction o Where should stenting be performed for obstructive bowel due to colorectal cancer o Who should carry out stenting for obstructed bowel due to colorectal cancer 10. New evidence was identified in these areas, particularly in relation to: 3 of 29

4 Specialisation of services conferring a benefit to patients with early rectal cancer: o Three studies indicated that specialisation of services and MDTs had improved both patient outcomes (reduced recurrence, increased survival rates) and management outcomes (improved investigations, increase local excision rate). o Two studies highlighted the importance of pathological reporting to the MDTs for patients with rectal cancer. With a study also reporting the need for protocols and close team working with a range of clinical specialists. Furthermore, 2 studies indicated that MDT discussion and preoperative decision making significantly increased patients outcomes for rectal cancer and the effectiveness of the MDT. Technical success for stenting obstructive bowel been dependent on the experience of the clinician (surgeon endoscopist) performing the procedure not on the hospital type. Centre for Clinical Practice Director perspective 11. Feedback from the NICE Centre for Clinical Practice Director for the Organisation of care for early rectal cancer indicated: o Early rectal cancer, as defined by superficial lesions not requiring a full anterior resection, is a rare condition but it is becoming more common due to the development of the bowel cancer screening programme. o The basic principles of (cancer) service guidance are that key clinical decisions should be made by MDTs composed of professional staff who are specialised in that cancer and that, where necessary to secure specialisation, the decision-making and management of cases may need to be centralised. o In the case of early rectal cancer, the key issues concern precision in staging, selection of patients for minimal resection and decisions on further treatment. Application of the above principles suggest that these decisions should reside in teams which treat more of 4 of 29

5 these cases than would be seen by the typical colorectal MDT and that, therefore, some degree of sub-specialisation at team level would be appropriate. It is also inevitable that in order to select the patients who would be suitable for local resection, a larger number of patients with limited stage rectal cancer would have to be considered. Management of emergency presentation of colon cancer with bowel obstruction indicated: o o These patients have the poorest prognosis yet, paradoxically, are those least likely to be diagnosed and managed by specialist colorectal surgeons. The trial comparing surgery with stenting constitutes only one part of the scenario. The philosophy is that stenting might offer a bridge between emergency presentation and the definitive treatment by specialist members of the MDT. Evidence of the safety and effectiveness of stenting for this purpose is awaited. European trials in this area were generally terminated early due to poor outcomes in the stenting group but the arrangements for implementing stenting in England have been much more tightly controlled than in Europe and the possibility of a non-inferiority outcome is genuine. The broader issue concerns the organisation of colorectal surgical teams in such a way as to ensure that all patients presenting with obstruction due to bowel cancer are first assessed by specialists in the field. Current arrangements in hospitals in England are such that few, if any, can guarantee that this would be the case. The potential reorganisation of services, or the development of clinical team relationships to be able to offer specialist care at any time, would not be without its challenges but it is acknowledged as the ideal position. 5 of 29

6 Expert focus group perspective 12. A questionnaire and a briefing paper presenting the current epidemiological data, new literature and initial intelligence gathering was distributed to 9 members of an expert focus group (comprising of gastroenterologists, colorectal surgeons, pathologists and radiologists) to consult them on the need for an update of the organisation and management of services for early rectal cancer and arrangement of services for the management of bowel obstruction caused by colon cancer) sections of the colorectal cancer service guidance. The briefing paper concluded that the cancer service guidance for colorectal cancer should be updated to consider the issuing of additional guidance on: The organisation and management of services for early rectal cancer The arrangement of services for the management of bowel obstruction caused by colon cancer. 13. Six responses were received with 4 respondents providing feedback in relation to early rectal cancer services and 5 providing feedback in relation to stenting for emergency bowel obstruction. All respondents agreed with the areas suggested for update in the briefing document. 14. For early rectal MDTs, in general respondents suggested that, since the previous guidance was published, changes to epidemiology and clinical practice in both medical oncology, diagnosis and surgery for early rectal cancer have occurred. This included: A rising incidence of early rectal cancer. Developments in imaging of early rectal cancer Alternative treatments have been developed. This includes treatments that preserve the rectum which are currently being formally evaluated. The guidance had not been adopted nationally 15. Suggested key areas for service guidance to address and provide recommendations on included: 6 of 29

7 The level of workload required to gain expertise for an MDT (including the requisite radiology and radiotherapy services ) Clearer definition of membership and role of specialist MDTs (including links to data collection and research) The remit area of interest of specialist MDT- i.e. should consider significant rectal neoplasia as opposed to just cancer Referral pathways 16. For stenting for emergency bowel obstruction the respondents all highlighted concerns relating to the evidence for the safety and effectiveness of stenting for emergency bowel obstruction presented in CG131 and suggested that the CREST trial should be utilised to ascertain if this procedure should still be considered as an appropriate treatment option. The respondents indicated that to enable a fully informed decision-making process for any service design that an update should wait until this data is available (1-2 years). 17. In addition the respondents highlighted that clear recommendations relating to the following aspects would be welcome: The reorganisation of services, or the development of clinical team relationships to be able to offer specialist care at any time Clear definition of referral pathway for discussing and transferring patients with colonic obstruction who may benefit from stenting. 18. In summary, all 6 respondents felt that there have been sufficient changes in the knowledge base and clinical practice to warrant an update of the organisation and management of services for early rectal cancer and arrangement of services for the management of bowel obstruction caused by colon cancer) sections of the colorectal cancer service guidance 7 of 29

8 Initial intelligence gathering 19. The following relevant information on the organisation and management of services for early rectal cancer specifically MDTs and arrangement of services for the management of bowel obstruction caused by colon cancer was obtained through a scoping search of the clinical area. 20. The NICE Clinical Guideline 131 Colorectal cancer: the diagnosis and management of colorectal cancer made specific recommendations with regard to early rectal cancer MDTs and colonic stenting of patients with bowel obstruction due to colorectal cancer. 21. The Department of Health (2011) Manual for cancer services - Colorectal measures version 3.1 stated due to the likelihood of some degree of service reconfiguration, the network board in consultation with the Network Site Specific Groups (NSSG) should decide the network configuration of the all colorectal MDTs that deal with local excision of early rectal cancer. The MDT team criteria and locations were then placed as colorectal specific network board measures. o Additionally the NSSG should also agree in consultation with the MDTs, network-wide guidelines for the management of early rectal cancer Colorectal measures includes measures to ensure that those practising colorectal stenting for a network are judged as being competent and that the practice is limited to these named personnel. There are also measures to form agreements on which hospital will admit surgical emergencies and network-wide guidelines for the management of surgical emergencies related to colorectal cancer. 22. The National Cancer Peer Review Programme report 2010/2011 on colorectal MDTs: Did not report any measures relating to particular MDTs having the expertise in the management of early rectal cancer and the referral processes to these teams. 8 of 29

9 Stated that there were immediate risks based on their measures for colorectal stenting with 8 teams having surgeons who were operating on less than 20 cases a year. In addition there were immediate risks and serious concerns in discrepancies in personnel authorised to perform stenting, personnel not on the approved list for stenting and arrangements for colorectal emergencies. The Colorectal Cancer Surgery Standards 2012 report suggested that colorectal MDTs should deal with a minimum of 60 new cases of colorectal cancer per year and for individual core surgical team members to undertake a minimum per year of 20 elective resections of colorectal cancer with curative intent. A large multicentre RCT (CReST) is underway in the UK that is investigating the role of endoluminal stenting in the acute management of obstructing colorectal cancer trial. On completion this trial may provide evidence on the role of stenting in bowel obstruction caused by colon cancer. Implementation and post publication feedback 23. In total 27 enquiries were received of which all were standard or nonstandard. In general the enquiries were for either hard copies of the guidance or requests for information relating to individual clinical cases or further information for practice. None related to the two areas for review. 24. The National bowel cancer audit data indicates: The number of patients with colorectal recorded as being discussed at an MDT meeting has increased year on year from 80.3% in 2006/7, 83.7% in 2007/8, 96.3% in 2008/09 to 97.6% in 2009/10. Local excision rates for rectal cancers are increasing from 216 (4%) in 2008/09 to 379 (6.3%) in 2009/10 of all the patients presenting with rectal cancer. 9 of 29

10 Patients undergoing urgent and emergency surgery for colorectal cancer had a 30-day post-operative mortality of 6.4% and 11.4% respectively compared to 2.3% and 3.1% for elective and scheduled surgery in 2009/10. Individuals dying rapidly were significantly more likely to have presented to the NHS as an emergency than those who survived for more than a month. Hospital Episodes Statistics (HES) data indicates a gradual decline in the number of emergency colorectal resection procedures carried out on people with a diagnosis of colon cancer between 2000/01 and 2010/11 in England. Whilst the number of metallic colonic stents procedures on people with a diagnosis of colon cancer has risen sharply since 2005/2006 reaching 300 by 2010/2011. Relationship to other NICE guidance 25. NICE guidance related to Cancer Service Guidance: Improving outcomes in colorectal cancer (organisation of services for early rectal cancer and emergency bowel obstruction due to colorectal cancer sections) can be viewed in Appendix 1. Summary of Feedback Review proposal put to consultees: The guidance should be considered for an update. 26. In total 7 stakeholders commented on the review proposal recommendation during the two week consultation period. The table of stakeholder comments can be viewed in Appendix Six stakeholders agreed with the review proposal and 1 stakeholder offered no opinion on the proposal. 10 of 29

11 Anti-discrimination and equalities considerations 28. No evidence was identified to indicate that there are any discriminatory or equalities issues within colorectal cancer service provision. Relationship to quality standards 29. This topic is part of the library of NICE Quality Standard NHS healthcare topics. 30. This topic is related to a published quality standard. Conclusion 31. From the evidence and intelligence gathering identified through the process, it suggests that some areas of the colorectal cancer service guidance may need updating to consider the issuing of additional guidance on: a) The organisation and management of services for early rectal cancer b) The arrangement of services for the management of bowel obstruction caused by colon cancer. However, it may be pertinent to postpone the update until ongoing clinical trials within these areas publish. 32. Guidance Executive confirmed that Centre capacity will be prioritised to accommodate new topic referrals. Where there is currently a published quality standard or where a quality standard is not required, guideline updates will be subject to NICE scheduling processes at a later date. Mark Baker Centre Director Sarah Willett Associate Director Katy Harrison Technical Analyst Centre for Clinical Practice 18 December of 29

12 Appendix 1 The following NICE guidance is related to Cancer Service Guidance: Improving outcomes in colorectal cancer (organisation of services for early rectal cancer and emergency bowel obstruction due to colorectal cancer sections): Guidance CG131 Colorectal cancer: the diagnosis and management of colorectal cancer 2011 Related NICE quality standard QS20 Colorectal cancer 2012 Review date Review date: 2014 TBC 12 of 29

13 Appendix 2 National Institute for Health and Clinical Excellence Cancer Service Guidance: Improving outcomes in colorectal cancer Guideline Review Consultation Table November 2012 Agree SH Birmingham Clinical Trials Unit Yes Letter of appeal as sent to NICE following the Colorectal Cancer Guidelines. 23rd January 2012 Dear Chair, Re: Appeal Against Recent Colorectal Cancer Guidelines Clinical Guideline on Diagnosis and Management of Colorectal Cancer, Clinical question: For patients presenting with acute large bowel obstruction as a first presentation of colorectal cancer, what are the indications for stenting as a bridge to elective surgery The University of Birmingham wrote to the Thank you for your comments. The letter of appeal you have enclosed relates to CG131. However, the evidence that you have submitted will be passed on to the 13 of 29

14 developers to comment on the draft guidance on use of Self Expanding Metal Stents (SEMS) in patients with obstructing left sided colorectal cancer (see attached). Our central concern about the draft guidance was that it did not refer to or discuss three recently published randomised controlled trials. These trials meet the criteria for Level 1 evidence and they raise significant and serious concerns about the safety and efficacy of inserting SEMS in patients with acute large bowel obstruction as a first presentation of colorectal cancer. These trials could not be more directly relevant to the clinical question posed by the guideline development group. Surprisingly, however, the developers response to our stakeholder comments (page 192) was to cite 2004 guidance recommending SEMS (which was made before any of the RCTs reported) and to state that the evidence cited related to the issue of stent insertion vs emergency surgery and was therefore not relevant to the topic considered by the guideline. This indicates a fundamental misunderstanding of the clinical options for management of obstructing colon cancer, which are either SEMS as a bridge to elective surgery or immediate emergency surgery. The comparison of stent vs emergency surgery is, therefore, precisely the question the guideline authors needed to address to define the indication for SEMS. Indeed, this is explicit in several sections of the Guidelines: e.g. the decision [to stent] must balance the risks between stent insertion and emergency guideline developers for consideration during the update process. 14 of 29

15 surgery (page 74, para 4). The developers response to our comments is therefore simply wrong. As a consequence, the Guidance recommendations are based on data from retrospective case series that appear too good to be true and are incompatible with those from the randomised trials, e.g. a technical success rate of 100% (34/34), with 95% CI: %, in Iversen s retrospective Danish series compares to 47% (14/30) in the French randomised trial. The other newly found data from Vemulapalli et al, widely cited in the Guidance, is not even relevant to the question addressed as it includes only patients with metastatic disease for whom stenting was a palliative procedure and not undertaken as a bridge to surgery. The failure to consider relevant Level 1 evidence ( The GDG noted that there were no studies which were directly applicable to this topic, page 71) indicates either a serious misunderstanding of the topic reviewed, or a failure to exercise due diligence in the development of the Guidance on SEMS, with either explanation being sufficient to invalidate the NICE recommendations. Guidance that ignores relevant directly randomised evidence on the question addressed is obviously indefensible and does a disservice to patients and their medical carers. As this randomised evidence points to the potential for serious harm as a result of insertion of SEMS in patients with obstructing colorectal cancer, the NICE Guidance s recommendation that 15 of 29

16 colorectal surgeons should consider inserting a colonic stent in patients presenting with acute large bowel obstruction, without mention that randomised trials have failed to establish superiority of SEMS over decompression surgery, is perverse. The appropriate recommendation - and the conclusion of the authors of all three randomised trials (see below) - is that stenting as a bridge to surgery remains an experimental procedure requiring further randomised evidence to establish its clinical and cost-effectiveness. The newly published guidance on SEMS should be corrected or withdrawn. We declare our interest as organisers of CReST, the NCRI s ongoing Cancer Research UK-funded randomised trial comparing SEMS versus emergency surgery. James Hill Consultant Colorectal Surgeon & Chief Investigator, CReST Trial Richard Gray Professor of Medical Statistics Lead Statistician for the CReST Trial Dion Morton Professor of Surgery, Chair of the NCRI Surgical Trials Subcommittee & Clinical 16 of 29

17 Director to the Research Department, Royal College of Surgeons of England Will Steward Professor of Surgery Chair of the NCRI Colorectal CSG Nigel Scott Professor of Surgery & President of the Association of Coloproctology of Great Britain and Ireland David Jayne Professor of Surgery & Chairman of the Research & Audit Committee of the Association of Coloproctology of Great Britain and Ireland Clive Kay Professor of Radiology Lead Radiologist for the CReST Trial Simon Jackson Consultant Radiologist President of the British Society of Gastrointestinal and Abdominal Radiology 17 of 29

18 Conclusions of the three published randomised trials assessing SEMS as a bridge to elective surgery: In conclusion, our study has shown that colonic stenting for acute malignant obstruction as a bridge to surgery is neither safer nor more effective for relief of obstruction than traditional surgery in the emergency setting. Further studies are necessary to compare the carcinologic outcomes of the two reported strategies. Pirlet IA, Slim K, Kwiatowski F, et al. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc 2011; 25: Colonic stenting has no decisive clinical advantages to emergency surgery. Future studies need to further investigate oncological outcomes and establish whether specific groups of patients could have a greater benefit from either colonic stenting or emergency surgery. van Hooft JE, Bemelman WA, Oldenburg B, et al. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol 2011; 12: Further large-scale studies to investigate the long-term oncologic outcomes of this approach are warranted. Cheung HYS, Chung CC, Tsang WWC, et al. Endolaparoscopic Approach vs Conventional Open Surgery in the Treatment of 18 of 29

19 SH Birmingham Clinical Trials Unit Yes Obstructing Left-Sided Colon Cancer A Randomized Controlled Trial. Arch Surg. 2009;144: Also shown below is our letter to NICE on the Draft Quality Standards (statement 5) Dear Sir We are writing to express our strong concern about the inappropriate recommendation (quality statement 5) that people with acute left-sided large bowel obstruction should be offered a colonic stent. This recommendation is based on NICE clinical guideline 131, which we are currently appealing against (see attached) on the grounds that the Guideline Development Group did not consider the evidence from three directly relevant randomised trials1-3 comparing colonic stent with emergency surgery for large bowel obstruction. All three trials closed prematurely because of concerns about the safety and efficacy of colonic stents and the conclusions of all three reports was that stenting as a bridge to surgery remains an experimental procedure of uncertain clinical and cost-effectiveness and thus should only be used within a well-designed research study. Such a study ( CReST ) is currently ongoing in the UK, funded by Cancer Research UK, and the appropriate quality statement for patients presenting with obstructing left-sided colon cancer should be - as with the NICE guidelines on carotid stenting for asymptomatic carotid stenosis4 that this procedure should only Thank you for your comment. The final Quality standard did not include the quality statement to which you refer. 19 of 29

20 be used with special arrangements for clinical governance, consent and audit or research: clinicians should, preferably, enter such patients into the CReST trial. A quality statement that they should not do so is simply wrong, potentially discredits the valuable Clinical Guideline and Quality statement process and is causing wide concern among those involved in treating and researching colorectal cancer as evidenced by the willingness of the number of relevant bodies who support this objection. We hope that sense will prevail. James Hill (Consultant Colorectal Surgeon & Chief Investigator, CReST Trial), Richard Gray (Professor of Medical Statistics & Lead Statistician for the CReST Trial), Clive Kay (Professor of Radiology & Lead Radiologist for the CReST Trial), Dion Morton (Professor of Surgery, Chair of the NCRI Surgical Trials Subcommittee & Clinical Director to the Research Department, Royal College of Surgeons of England), Will Steward (Professor of Medical Oncology & Chair of the NCRI Colorectal Cancer Clinical Study Group), Nigel Scott (Professor of Surgery & President of the Association of Coloproctology of Great Britain and Ireland), David Jayne (Professor of Surgery & Chairman of the Research & Audit Committee of the Association of Coloproctology of Great Britain and Ireland), Simon Jackson (Consultant Radiologist & President of the British Society of Gastrointestinal and Abdominal Radiology) 20 of 29

21 References 1. Pirlet IA, Slim K, Kwiatowski F, et al. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc 2011; 25: van Hooft JE, Bemelman WA, Oldenburg B, et al. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol 2011; 12: Cheung HYS, Chung CC, Tsang WWC, et al. Endolaparoscopic Approach vs Conventional Open Surgery in the Treatment of Obstructing Left-Sided Colon Cancer A Randomized Controlled Trial. Arch Surg. 2009;144: pdf SH Birmingham Clinical Trials Unit Yes Online Publication letter to BJS following the publication of NICE Guidance Systematic review and meta-analysis of randomized clinical trials of self-expanding metallic stents as a bridge to surgery versus emergency surgery for malignant left-sided large bowel obstruction Br J Surg 2012;99: Thank you for your comment. The new evidence that you have provided with regard to colonic 21 of 29

22 We welcome the meta-analysis by Tan and colleagues of self expanding metal stents (SEMS) as a bridge to surgery for malignant left-sided bowel obstruction. The authors correctly highlight low success rates for stenting and high perforation rates and they emphasise concerns about long term oncological outcomes. Many questions remain about stenting in obstructing colorectal cancer. These include 30 day mortality, length of hospital stay, quality of life, overall and disease free survival, critical care requirements, cost benefit analysis and rate of adjuvant chemotherapy. NICE Clinical Guidelines on (SEMS) for acute large bowel obstruction 1 raise concerns about the quality of NICE evidence reviews and guidance. We as stakeholders pointed out that three directly relevant randomised controlled trials (all included in Tan s meta-analysis) were not referred to, or discussed, in the draft Guidelines on SEMS: all three trials closed prematurely because of safety and efficacy concerns2-4. NICE guidelines are, instead, based on non-randomised data statistically incompatible with data from randomised trials. The developers responded, wrongly, that the trials were not relevant because they compared stent insertion with emergency surgery (page 192).5 This indicates either a serious misunderstanding of the topic reviewed, or a failure to exercise due diligence in the development of the guidance on SEMS. The appropriate stenting will be passed on to the guideline developers for consideration during the update process. 22 of 29

23 recommendation, supported by this meta-analysis - and the conclusion of the authors of all three randomised trials2-4 - is that stenting as a bridge to surgery remains of uncertain clinical and cost-effectiveness and thus should only be used within a well-designed research study. James Hill Consultant Colorectal Surgeon & Chief Investigator, CReST Trial Richard Gray Professor of Medical Statistics Lead Statistician for the CReST Trial Dion Morton Professor of Surgery, Chair of the NCRI Surgical Trials Subcommittee & Clinical Director to the Research Department, Royal College of Surgeons of England Will Steward Professor of Medical Oncology Chair of the NCRI Colorectal Cancer Clinical Study Group 23 of 29

24 Nigel Scott Professor of Surgery & President of the Association of Coloproctology of Great Britain and Ireland David Jayne Professor of Surgery & Chairman of the Research & Audit Committee of the Association of Coloproctology of Great Britain and Ireland Clive Kay Professor of Radiology Lead Radiologist for the CReST Trial Simon Jackson Consultant Radiologist President of the British Society of Gastrointestinal and Abdominal Radiology We declare our interest as organisers of CReST, the NCRI s ongoing Cancer Research UK-funded randomised trial comparing SEMS versus emergency surgery. 24 of 29

25 SH Boston Scientific UK & Ireland Yes 1. NICE.: Colorectal Cancer; The diagnosis and Management of Colorectal Cancer: full guideline. Available at: (accessed 7 February 2012) 2. Pirlet IA, Slim K, Kwiatowski F, et al. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc 2011; 25: van Hooft JE, Bemelman WA, Oldenburg B, et al. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol 2011; 12: Cheung HYS, Chung CC, Tsang WWC, et al. Endolaparoscopic Approach vs Conventional Open Surgery in the Treatment of Obstructing Left-Sided Colon Cancer A Randomized Controlled Trial. Arch Surg. 2009;144: NICE. Colorectal cancer: consultation table with developers responses. Available at: (accessed 7 February 2012). We fully support the recommendation to update the Colorectal Cancer service guidance for the two aspects of the Improving Outcomes Guidance for Colorectal Cancer (relating to service delivery aspects of early rectal cancer multi-disciplinary teams Thank you for your comment. 25 of 29

26 SH Boston Scientific UK & Ireland Yes (MDT) and for the management of emergency bowel obstruction due to colon cancer). The conclusions indicate that Conclusion From the evidence and intelligence gathering identified through the process, it suggests that some areas of the colorectal cancer service guidance may need updating to consider the issuing of additional guidance on: a) The organisation and management of services for early rectal cancer b) The arrangement of services for the management of bowel obstruction caused by colon cancer. However, it may be pertinent to postpone the update until ongoing clinical trials within these areas publish. Thank you for your comment. The timing of the update will determined by a combination of the NICE work programme and evidence availability. SH SH Department of Health National Cancer Research Institute, Royal Agree We would urge NICE not to postpone the review until the Crest trial is reporting results: the study started enrolling in The target was 400 patients. However as of August 2012 there were only 158 patients enrolled. Therefore it is unlikely the study will provide results in a reasonable time. I wish to confirm that the Department of Health has no substantive comments to make, regarding this consultation. With respect to early rectal cancer, our experts believe that most pertinent points are covered by this document. It remains a niche area with special diagnostic, therapeutic and surveillance needs that are well suited to a centralised model as numbers are Thank you for your comment. Thank you for your comment. 26 of 29

27 College of Physicians, Royal College of Radiologists, Joint Collegiate Council for Oncology, Association of Cancer Physicians unlikely to support wider provision of these services in the near future. Demonstrating expertise within the multidisciplinary team in addition to appropriate unit caseloads, with additional research involvement would provide a clear basis for accreditation. In the opinion of some experts this could be delivered nationally in a short period of time as such units already exist throughout the UK. The next step would be to enable all patients diagnosed with small but significant lesions in the rectum to access specialist services for early rectal cancer, as we have done previously for anal cancer. Our experts suppose that currently only a small proportion of patients are being passed on to these teams. There is a risk that continued focus upon a minimum number of radical surgical resections per consultant within the NICE guidance may serve to hinder progress in some areas as inclusion of these early cancers can be used to bolster an individual s credentials. Unfortunately this means that the patient may not have been either well briefed or optimally treated. Removing these early stage cancers from that numbers game would mitigate against any vested interest and so help focus on delivering best patient care. SH Royal College of Nursing Yes There is justification for review of Colonic stents based on changing usage. Thank you for your comment. 27 of 29

28 SH Royal College of Pathologists yes However the evidence on which the case for reconsidering low rectal cancer management seems weaker and may not warrant a review at present Early rectal cancer MDTs Their introduction would be beneficial especially in dealing with the 3X increase in pt1 cancers from screening. They should have TEM experience and level 4 endoscopy skills plus excellent MRI/ultrasound and pathology Yes need equal access Thank you for your comment. These will be passed on to the developers for the update SH SH Royal College of Pathologists Teenagers and Young Adults with Cancer Yes yes Whilst the TREC trial is slow to recruit review of access of patients to stenting would be valuable but should also consider emergency colostomy and subsequently restoring fluid balance and staging the patient to reduce the high level of mortality in this group TYAC represents the professionals that work with young people with cancer. Colorectal cancer is very rare in young people but does happen. TYAC requests that reference is made to the fact that all year olds that are diagnosed with colorectal cancer need referring to the local Teenage and young Adult MDT for discussion as well as site specific discussion. Recommendation s on managing the obstructed emergency patient Yes need equal access Thank you for your comment. These will be passed on to the developers for the update. Thank you for your comment. These will be passed on to the developers for the update. 28 of 29

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