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Dye chromoENDOscopy versus virtual chromoendoscopy for assessment of the ileo-anal pouch in patients with familial adenomatous POLyposis: a randomized controlled trial

Dye chromoENDOscopy versus virtual chromoendoscopy for assessment of the ileo-anal pouch in patients with familial adenomatous POLyposis: a randomized controlled trial - ENDOPOL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53246
Enrollment
150
Registered
2023-08-21
Start date
2024-01-10
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial adenomatous polyposis (FAP) heriditary colon cancer

Interventions

Both interventions are standard care for detecting adenomas. 1. Virtual chromoendoscopy 2. Dye chromoendoscopy

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of FAP - Genetic diagnosis: proven APC germline mutation - Clinical diagnosis: >100 colorectal adenomas in combination with a positive family history of FAP Have an ileal-pouch anal anastomosis (IPAA) - After primary proctocolectomy or - secondary protectomy after initial colectomy with ileorectal or ileosigmoidal anastomosis (IRA/ISA) Age >= 18 years.

Exclusion criteria

Exclusion criteria: Allergy to indigo carmine (fluid which is used with dye chromoendoscopy). Patients who are unwilling or unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the detection of clinical relevant adenomas (>= 5mm) in the ileal pouch.

Secondary

MeasureTime frame
Secondary outcomes include: - Detection of advanced neoplasia in the ileal pouch, defined by advanced adenoma (>=10mm and/or and adenoma with high-grade dysplasia) or cancer. - Detection of adenomas 1-4mm, 5-9mm and >=10mm both in the pouch body and rectal remnant with WLE, NBI and dye-based chromoendoscopy - Number of performed polypectomies - Chosen interval for next surveillance endoscopy - Insight Polyposis Staging System (IPSS) score (10) - Duration of examination - Incidence of endoscopy-related complications

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)