Dye-based vs virtual chromoendoscopy for pouch surveillance in FAP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicenter randomized trial compares dye-based chromoendoscopy using Indigo Carmine with virtual chromoendoscopy (NBI/BLI) during surveillance pouchoscopy in adults with familial adenomatous polyposis and an ileal pouch-anal anastomosis. Participants are randomized 1:1 to either technique and undergo their usual endoscopic surveillance, with any adenomas treated as per standard practice during the same procedure. The study aims to generate high-quality evidence to inform the preferred chromoendoscopy approach in this setting, where current guidelines are inconclusive. The anticipated duration is about two years, and procedures are performed by endoscopists experienced in FAP).

Why it matters

Who can join: the full rules

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

Where it's running

• St Mark's Hospital Polyposis Registry (St Mark's Centre for Familial Intestinal Cancer)
  London, London, United Kingdom Recruiting

Study contacts

• Principal investigator: Andre Latchford, MBBS PhD FRCP — London North West University Healthcare Nhs Trust
• Study coordinator: Andrew Latchford, MBBS PhD FRCP
• Email: andrew.latchford@nhs.net
• Phone: +442088643232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.