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Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis

Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis - Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with FAP

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009365
Enrollment
200
Registered
2012-11-24
Start date
2012-11-24
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

familial adenomatous polyposis

Interventions

Sponsors

AMED
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have (or had) 100 or more adenomas in the large intestine and who refused to undergo surgery despite of being advised to do so, and who are 16 years or older (parental consent is required in patients younger than 20 years). Patients who have (or had) 100 or more adenomas in the large intestine and who had part of the large intestine resected by surgery but still have 10 cm or more of the large intestine, and who are 16 years or older (parental consent is required in patients younger than 20 years).

Exclusion criteria

Exclusion criteria: Patients who are considered by their attending physicians to be ineligible to participate in the study because they have a serious disease in other organs, or because they cannot discontinue antiplatelet drugs, or for other reasons. Patients who are receiving anticancer drugs. Patients with dense FAP in at least one-third of the large intestine. Patients in whom strict follow-up is difficult.

Design outcomes

Primary

MeasureTime frame
Whether or not a patient needs surgery on the large intestine during the intervention period. It includes not only the development of a polyp that cannot be removed endoscopically or that of large intestinal cancer, but also cases where a patient wishes to undergo resection of the large intestine because of discomfort of endoscopic examination, and cases where emergency surgery is performed because of perforation occurred during endoscopic treatment.

Secondary

MeasureTime frame
Presence or absence of the development of adverse events (perforation, hemorrhage, death from large intestinal cancer, and death from other causes), colorectal cancer, intramucosal carcinoma, or a tumor that is difficult to treat endoscopically.

Countries

Japan

Contacts

Public ContactHideki Ishikawa

Graduate School of Medical Science, Kyoto Department of Molecular-Targeting Cancer Prevention

cancer@gol.com06-6202-5444

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026