[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648675":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":24,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"London North West Healthcare NHS Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Chromoendoscopy","ACTIVE_COMPARATOR","Chromoendoscopy arm using dye spray",[13],"Other: Chromoendoscopy (Indigo Carmine)",{"label":15,"type":10,"description":16,"interventionNames":17},"Virtual Chromoendoscopy","Virtual chromoendoscopy arm using narrow-band imaging (NBI)",[18],"Other: Virtual Chromoendoscopy",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Chromoendoscopy (Indigo Carmine)","Chromoendoscopy using dye spray",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Virtual chromoendoscopy using narrow-band imaging (NBI)",[15],[29],{"name":30,"affiliation":31,"role":32},"Andre Latchford, MBBS PhD FRCP","LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Andrew Latchford, MBBS PhD FRCP","CONTACT","+442088643232","andrew.latchford@nhs.net",{"name":40,"role":36,"phone":37,"phoneExt":24,"email":41},"Benjamin Zare, MBChB (Hons) MRCP","b.zare@nhs.net",[43],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"St Mark's Hospital Polyposis Registry (St Mark's Centre for Familial Intestinal Cancer)","RECRUITING","London","N10 7NS","United Kingdom","UK",{"type":51,"coordinates":52},"Point",[53,54],-0.12574,51.50853,{"lat":54,"lon":53},[57,58],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},{"name":40,"role":36,"phone":37,"phoneExt":24,"email":41},{"type":60,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[62],{"name":63,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","100648675","evaluation-of-the-ileo-anal-pouch-in-fap-endopol-100648675",false,"NCT07726771","Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL)","ENDOPOL: Dye chromoENDOscopy Versus Virtual Chromoendoscopy for Assessment of the Ileo-anal Pouch in Patients With Familial Adenomatous POLyposis: a Randomized Controlled Trial","ENDOPOL","Inclusion Criteria:\n\nALL of the following:\n\n1. Diagnosis of FAP i.e., at least one of following:\n\n   * Genetic diagnosis: proven APC germline mutation OR\n   * Clinical diagnosis: \\>100 colorectal adenomas in combination with a positive family history of FAP\n2. Have an ileal-pouch anal anastomosis (IPAA), either after primary proctocolectomy or secondary proctectomy after initial colectomy and ileorectal or ileosigmoidal anastomosis (IRA\u002FISA)\n3. Age ≥ 18 years\n\nExclusion Criteria:\n\nANY of the following\n\n1. Diagnosis of FAP i.e., at least one of following:\n\n   * Genetic diagnosis: proven APC germline mutation OR\n   * Clinical diagnosis: \\>100 colorectal adenomas in combination with a positive family history of FAP\n2. Have an ileal-pouch anal anastomosis (IPAA), either after primary proctocolectomy or secondary proctectomy after initial colectomy and ileorectal or ileosigmoidal anastomosis (IRA\u002FISA)\n3. Age ≥ 18 years","ALL","18 Years",{"count":75,"type":76},50,"ESTIMATED","INTERVENTIONAL",[79],"NA","This international, multi-centre randomised controlled trial will compare dye-based chromoendoscopy with virtual chromoendoscopy, using NBI\u002FBLI, for adenoma detection during routine surveillance pouchoscopy in adults with familial adenomatous polyposis (FAP) and an ileal pouch-anal anastomosis (IPAA). The estimated study duration is 2 years. Participants will undergo their usual scheduled pouchoscopy, performed by endoscopists experienced in FAP. Before the procedure, they will be randomised 1:1 to dye-based or virtual chromoendoscopy. Adenomas requiring endoscopic treatment will be removed during the same procedure according to standard practice.\n\nTo our knowledge, no previous study has directly compared these techniques in this setting. Current guidelines recommend surveillance in patients with FAP and a pouch and permit dye-spray chromoendoscopy, but do not specify whether dye-based or virtual chromoendoscopy should be preferred. Practice varies between centres: virtual chromoendoscopy is commonly used at St Mark's Hospital, while some European centres primarily use dye-based chromoendoscopy. This study therefore aims to standardise practice and generate evidence to inform future surveillance strategies.\n\nEligible patients will be adults aged ≥18 years with FAP, defined by a proven APC germline mutation or a clinical diagnosis of \\>100 colorectal adenomas with a positive family history, and who have undergone IPAA after primary proctocolectomy or secondary proctectomy following IRA\u002FISA. Patients will be identified through routine endoscopy booking systems. Those who have consented to email communication from the Polyposis Registry team will receive a Participant Information Sheet in advance. They will be approached again on the day of their procedure, given the opportunity to ask questions, and consented before randomisation. Patients who do not consent will undergo their planned pouchoscopy as normal, without study randomisation. Patients lacking capacity to consent will not be approached.\n\nRandomisation will be performed using an independent computer-generated programme within Castor EDC, with allocation in a 1:1 ratio. Block randomisation will ensure balanced distribution between arms within each centre, and stratification by centre will account for differences in patient characteristics and local practice. Blinding is not feasible because dye-based and virtual chromoendoscopy have visually distinct appearances.\n\nDuring pouchoscopy, the pre-pouch ileum, pouch body and rectal cuff will be carefully inspected. In the dye-based arm, indigo carmine will be applied using a spray catheter before withdrawal and mucosal inspection. In the virtual chromoendoscopy arm, inspection will be performed using NBI\u002FBLI according to local platform availability. The endoscope will be advanced to the pre-pouch ileum, followed by systematic withdrawal and spiral mucosal inspection. Lesions will be documented by size and location, including pouch body and rectal remnant\u002Frectal cuff, using a polyp burden scoring table. Retroflexion will be performed to assess the rectal cuff. Polyp size will be estimated in millimetres, supported where appropriate by biopsy forceps of known size. Adenomas will be resected using standard polypectomy techniques where indicated, including polyps \\>5 mm in the pouch body, \\>2 mm in the rectal cuff, or lesions suspicious for high-grade dysplasia or early cancer.\n\nBecause assessment of small polyps can vary between endoscopists, particularly for lesions \\\u003C5 mm, endoscopic images will be used to assess inter-rater and intra-rater reliability for polyp burden and size. If reliability is acceptable, smaller polyps will be included and reported.\n\nQuality parameters will be collected for each procedure, including adjusted Boston Bowel Preparation Scale assessment for the pouch and total procedural time. Procedural time will include scope introduction, irrigation, dye application where applicable, withdrawal and inspection, retroflexion, and removal and retrieval of polyps.\n\nPost-procedure follow-up will follow routine care. Patients will be asked to monitor for adverse events after pouchoscopy and contact the hospital if needed. Future surveillance will be scheduled according to each centre's usual policy.\n\nStudy data will be held in routine hospital systems accessible to the patient's usual clinical team and in a study file. Participants will be assigned a study number. No identifiable patient information will leave the Trust or be accessible to anyone outside the usual care team. Anonymised data will be entered into Castor EDC. Pseudonymised data will be transferred to the central study team at Amsterdam University Medical Center under an existing data transfer agreement for pooled analysis.\n\nThe study does not expose participants to risks beyond routine surveillance pouchoscopy. There is no direct individual benefit but findings may benefit future patients with FAP and families by improving evidence.",[82,83],"Familial Adenomatous Polyposis (FAP)","Pouches, Ileoanal",[85,86,9,87,88],"FAP","Endoscopy","Dye spray","Pouch","2026-07-21",{"date":91,"type":92},"2026-07-24","ACTUAL",{"date":94,"type":92},"2026-07-09",{"date":96,"type":76},"2031-07-09",{"name":5,"class":6},1]