CLINICAL GUIDELINE FOR THE MANAGEMENT OF BARRETT S OESOPHAGUS Summary.

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1 CLINICAL GUIDELINE FOR THE MANAGEMENT OF BARRETT S OESOPHAGUS Summary. Page 1 of 12

2 Recurrent LGD at any point- discuss at MDT And consider RFA Patients with LGD should have a repeat endoscopy in 6 months. If LGD is found in any of the follow up OGDs and is confirmed by an expert GI pathologist, the patient should be offered endoscopic ablation therapy after clinical review and specialist MDT discussion. If ablation is not undertaken, 6- monthly surveillance is recommended It is the responsibility of the referring clinician to request follow up endoscopy It is the responsibility of the referring clinician to refer dysplasia to the MDT Page 2 of 12

3 Aim/Purpose of this Guideline This guideline applies to all patients with a histological diagnosis of Barrett s oesophagus and is relevant to all clinicians referring patients for upper gastrointestinal endoscopy. The Guidance Although RCT data are lacking, given the evidence from the published studies that surveillance correlates with earlier stage and improved survival from oesophageal cancer, endoscopic surveillance of Barrett s oesophagus is generally recommended Endoscopic monitoring with histopathological assessment of dysplasia is the only current method of surveillance with sufficient evidence to be recommended. 1. There is no current role for endoscopic screening for Barrett s. Cases will be diagnosed incidentally. 2. Endoscopic Assessment - Barrett s oesophagus is defined as an oesophagus in which any portion of the normal distal squamous epithelial lining has been replaced by metaplastic columnar epithelium, which is clearly visible endoscopically ( 1 cm) above the GOJ and confirmed histopathologically from oesophageal biopsies. The proximal limit of the longitudinal gastric folds with minimal air insufflation is the easiest landmark to delineate the GOJ and is the suggested minimum requirement 3. Biopsy protocol - The Seattle biopsy protocol (four-quadrant random biopsies every 2 cm in addition to targeted biopsies on macroscopically visible lesions) is recommended at the time of diagnosis and at subsequent. Targeted biopsy samples from visible lesions should be taken before random biopsies. Distal areas should be biopsied first starting 1 2 cm above the GOJ and advancing proximally to minimise obscured view from bleeding. 4. If a patient is unable to tolerate this procedure at the initial diagnostic OGD the patient is brought back at the earliest opportunity for further evaluation. Page 3 of 12

4 5. Report endoscopic reports should be standardised: Finding Reporting system Nomenclature Barrett's oesophagus Prague classification CnMn (where n is length in cm) length Barrett's Describe distance from the incisors and length Descriptive in the text islands in cm Hiatus hernia Distance between diaphragmatic pinch and GOJ yes/no; cm Visible lesions Number and distance from incisors yes/no; cm Classification of visible lesions Paris classification 0-Ip, protruded pedunculated 0-Is, protruded sessile 0-IIa, superficial elevated 0-IIb, flat 0-IIc, superficial depressed 0-III, excavated Biopsies Location and number of samples taken n cm (distance from incisors) n GOJ, gastro-oesophageal junction. 6. Histological assessment should be by a specialist in upper GI histopathology. Any dysplasia should be reviewed independently by another expert histopatholgist. 7. Patient Information - Patients should have early access to an outpatient clinic to be informed about a new diagnosis of Barrett s oesophagus and to have an initial discussion about the pros and cons of surveillance with written information provided. For a given patient, whether or not surveillance is indicated should be determined on the basis of an estimate of the likelihood of cancer progression and patient fitness for repeat endoscopies, as well as patient preference. Information should be provided from: Drug therapy Patients should be maintained on proton pump inhibitor. Barrett s alone is not an indication for Anti-reflux surgery Page 4 of 12

5 Management Of Barrett s oesophagus Page 5 of 12

6 9. Management of dysplasia a. All cases of dysplasia should be discussed at the upper GI cancer MDT b. It is the responsibility of the referring clinician to ensure the case is discussed c. A weekly data base check for oesophageal dysplasia will be performed by pathology and cases referred to cancer services for cross checking d. All histological cases should be double reported by a second specialist histopathologist e. Outcome from MDT will be summarised and recorded by cancer services f. The treatment plan will be discussed with the patient Management of Barrett s Dysplasia Recurrent LGD at any point- discuss at MDT And consider RFA Page 6 of 12

7 Monitoring compliance and effectiveness Element to be monitored Lead Tool Frequency Reporting arrangements Identification and outcomes for cases of dysplasia will be audited annually Governance and Endoscopy lead 1. Pathology data base weekly review 2. MDT records 3. Standardised endoscopic reporting Scorpio electronic reporting system Annual outcomes audit Quarterly scorpio audit (JAG review) Monthly pathology /cancer services Reported to: 1. Gastroenterology Governance meeting 2. Endoscopy users group Reports will be discussed in a clinical forum and recommendations made. Each meeting is minuted. Acting on recommendations and Lead(s) Change in practice and lessons to be shared Responsibility of the gastroenterology management team (service lead, clinical lead and governance lead) to act on recommendations. Report back to Divisional Board and Divisional Governance Meeting Actions will be implemented by the clinical leads in each area : governance, endoscopy Changes in practice and lessons learned will be discussed at the Gastroenterology Governance Meeting and the Endoscopy users Group Equality and Diversity.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website..2. Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 7 of 12

8 Appendix 1. Governance Information Document Title CLINICAL GUIDELINE FOR THE MANAGEMENT OF BARRETT S OESOPHAGUS Date Issued/Approved: Date Valid From: Date Valid To: Directorate / Department responsible (author/owner): Contact details: Brief summary of contents Suggested Keywords: Target Audience Executive Director responsible for Policy: Date revised: This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Divisional Manager confirming approval processes Name and Post Title of additional signatories Name and Signature of Divisional/Directorate Governance Lead confirming approval by specialty and divisional management meetings Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Dr N Michell, Department of Gastroenterology Dr N Michell, Department of Gastroenterology ext 2074 Standardised identification of Barrett s oesophagus, biopsy protocol, histological assessment and management plan Barrett s oesophagus, high grade dysplasia, low grade dysplasia RCHT PCH CFT KCCG Medical director New New Gastroenterology Governance Meeting Division of Medicine Governance Meeting Tim Mumford, Associate Director, Medicine, ED & WCH Not Required {Original Copy Signed} Name: Nick Michell, Gastroenterology Governance Lead {Original Copy Signed} Internet & Intranet Intranet Only Page 8 of 12

9 Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? Gastroenterology NA Version Control Table Date Version No Summary of Changes Changes Made by (Name and Job Title) 21 Nov 17 V1 New Nick Michell, Consultant Gastroenterology All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 9 of 12

10 Appendix 2. Initial Equality Impact Assessment Form This assessment will need to be completed in stages to allow for adequate consultation with the relevant groups. Name of Name of the strategy / policy /proposal / service function to be assessed Clinical Guidelines for the Management of Barrett s Oesophagus Directorate and service area: Medicine/ gastroenterology Name of individual completing assessment: Nick Michell, Consultant Gastroenterologist Is this a new or existing Policy? New Telephone: Policy Aim* Who is the strategy / policy / proposal / service function aimed at? This guideline applies to all patients with a histological diagnosis of Barrett s oesophagus and is relevant to all clinicians referring patients for upper gastrointestinal endoscopy. 2. Policy Objectives* To ensure that all patients undergoing endoscopic procedures have correct management of their condition 3. Policy intended All patients being referred for endoscopy have an evidence based plan Outcomes* created 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a Who did you consult with b). Please identify the groups who have been consulted about this procedure. Auditing numbers of referrals without such a management plan and also those where the plan is deemed inappropriate All patients with Barretts Oesophagus undergoing endoscopy Workforce Patients Local groups Please record specific names of groups External organisations Discussed amongst Gastroenterology colleagues Other Page 10 of 12

11 What was the outcome of the consultation? 7. The Impact Please complete the following table. If you are unsure/don t know if there is a negative impact you need to repeat the consultation step. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Unsure Rationale for Assessment / Existing Evidence Age Sex (male, female, trans-gender / gender reassignment) Race / Ethnic communities /groups Disability - Learning disability, physical impairment, sensory impairment, mental health conditions and some long term health conditions. Religion / other beliefs Marriage and Civil partnership Pregnancy and maternity Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major this relates to service redesign or development Page 11 of 12

12 8. Please indicate if a full equality analysis is recommended. Yes No 9. If you are not recommending a Full Impact assessment please explain why. x Does not meet the necessary criteria to warrant a full impact assessment. Signature of policy developer / lead manager / director Roz Davies, Directorate Manager, Specialty Medicine Date of completion and submission Names and signatures of members carrying out the Screening Assessment 1. Roz Davies, Specialty Medicine 2. Human Rights, Equality & Inclusion Lead Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD This EIA will not be uploaded to the Trust website without the signature of the Human Rights, Equality & Inclusion Lead. A summary of the results will be published on the Trust s web site. Signed Date Page 12 of 12

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