Treatment Outcomes of Advanced Neoplasia in IBD

Active, not recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Procedure: Endoscopic or surgical resection

• Registration Number: NCT05674773
• Lead Sponsor: Radboud University Medical Center

Brief Summary

In this study, we aimed to (1) compare cumulative incidences of synchronous and metachronous colorectal neoplasia as well as mortality following AN in CD and UC patients who underwent proctocolectomy, (sub)total colectomy, partial colectomy or endoscopic resection, and (2) to determine factors associated with AN treatment choice.

Detailed Description

In this retrospective multicenter cohort study, using PALGA (the Dutch nationwide pathology databank), partial colectomy yielded a similar metachronous neoplasia risk compared to (sub)total colectomy after treatment of advanced neoplasia in inflammatory bowel disease. High metachronous neoplasia rates after endoscopic resection underline the importance of strict subsequent endoscopic surveillance.

Study Timeline

• Study Start: 2019-05-21
• Status Verified: 2022-12
• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-29
• Last Update Submitted: 2022-12-29
• Primary Completion: 2022-12-31
• Study First Posted: 2023-01-06
• Last Update Posted: 2023-01-06
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• IBD (ulcerative colitis (UC), CD or IBD-unclassified (IBD-U))
• Histological diagnosis of colorectal AN
• Available treatment data

Exclusion Criteria

• Familial CRC syndrome
• AN prior to IBD diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD patients with advanced neoplasia	Endoscopic or surgical resection	IBD patients with advanced neoplasia (high-grade dysplasia or colorectal cancer) treated with: * proctocolectomy * (sub)total colectomy * partial colectomy * endoscopic resection

Primary Outcome Measures

Name	Time	Method
Synchronous	up to 6 months	defined as co-existence of two or more neoplastic colorectal lesions detected in the initial resection specimen or up to 6 months after treatment of the index lesion, categorized in (a) any neoplasia (independent of grade) and (b) only AN
Metachronous (advanced) neoplasia	up to 30 years	defined as colorectal neoplasia detected \>6 months after treatment of index AN, categorized in (a) any neoplasia (independent of grade) and (b) only AN, including the impact of IBD type

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	up to 30 years	All-cause mortality
Associations with treatment choice	up to 30 years	Clinical and disease characteristics associated with AN treatment choice

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands