- Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL) — Recruiting • Non-phase study • Oncology • NCT07726771.
- What is being tested: This RCT compares dye-based chromoendoscopy versus virtual chromoendoscopy (NBI/BLI technology) for detecting adenomas during surveillance pouchoscopy in FAP patients with ileal pouch-anal anastomosis (IPAA).
- Patient eligibility overview: The trial includes adults with FAP who have undergone IPAA surgery and require routine pouch surveillance as part of their standard cancer prevention care.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.