Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study

Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study - Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060166

Enrollment

280

Registered

2025-12-25

Start date

2024-12-25

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who visited Hyogo Medical University Hospital or participating institutions between January 1, 2016 and December 31, 2023, were clinically diagnosed with familial adenomatous polyposis (FAP), and were found to have duodenal adenomas or duodenal carcinoma on esophagogastroduodenoscopy during the observation period.

Exclusion criteria

Exclusion criteria: (a) Fewer than two EGDs during observation (b) Prior surgeries preventing duodenal observation (gastrectomy, pancreaticoduodenectomy, etc.) (c) Current or past chemotherapy for non-duodenal malignancies (d) Inflammatory bowel disease (e) Opt-out request from the participant

Design outcomes

Primary

Measure	Time frame
Difference in time until progression of Spigelman stage between patients at IDP group and those at non-IDP group.	—

Secondary

Measure	Time frame
Incidence of duodenal cancer and duodenal surgery in IDP vs. non-IDP groups Proportion of patients with stage IV Spigelman classification at 2 years after endoscopic treatment and at the final EGD Comparison of longitudinal Spigelman stage changes between IDP and non-IDP groups These secondary outcomes will be evaluated in a comprehensive and exploratory manner.	—

Countries

Japan

Contacts

Public ContactTakuya Okugawa

Hyogo Medical University School of Medicine Department of Gastroenterology

okugawat@hyo-med.ac.jp0798-45-6111

Outcome results