Condition: Familial Adenomatous Polyposis (FAP) · Pouches, Ileoanal · Sponsor: London North West Healthcare NHS Trust
This international, multi-centre randomised controlled trial will compare dye-based chromoendoscopy with virtual chromoendoscopy, using NBI/BLI, 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. To 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. Eligible 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 foll…
This description comes directly from the study's public registry record.
Andrew Latchford, MBBS PhD FRCP · +442088643232 · andrew.latchford@nhs.net
Benjamin Zare, MBChB (Hons) MRCP · +442088643232 · b.zare@nhs.net
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| St Mark's Hospital Polyposis Registry (St Mark's Centre for Familial Intestinal Cancer) | London, London, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07726771