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Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL)

RecruitingNAAges 18 Years - anyAllLondon North West Healthcare NHS Trust
NCT07726771 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 o

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📋 Eligibility rules (as published)
Inclusion Criteria: ALL of the following: 1. Diagnosis of FAP i.e., at least one of following: * Genetic diagnosis: proven APC germline mutation OR * Clinical diagnosis: \>100 colorectal adenomas in combination with a positive family history of FAP 2. Have an ileal-pouch anal anastomosis (IPAA), either after primary proctocolectomy or secondary proctectomy after initial colectomy and ileorectal or ileosigmoidal anastomosis (IRA/ISA) 3. Age ≥ 18 years Exclusion Criteria: ANY of the following 1. Diagnosis of FAP i.e., at least one of following: * Genetic diagnosis: proven APC germline mutation OR * Clinical diagnosis: \>100 colorectal adenomas in combination with a positive family history of FAP 2. Have an ileal-pouch anal anastomosis (IPAA), either after primary proctocolectomy or secondary proctectomy after initial colectomy and ileorectal or ileosigmoidal anastomosis (IRA/ISA) 3. Age ≥ 18 years
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What it tests

  • Chromoendoscopy (Indigo Carmine)
  • Virtual Chromoendoscopy
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Where

1 site
St Mark's Hospital Polyposis Registry (St Mark's Centre for Familial Intestinal Cancer)
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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