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Clinical Trials/NCT05674773
NCT05674773Active, not recruitingNot Applicable

Endoscopic and Surgical Treatment Outcomes of Colitis-associated Advanced Neoplasia: a Multicenter Cohort Study

Radboud University Medical Center1 site in 1 country189 target enrollmentStarted: May 21, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
189
Locations
1
Primary Endpoint
Synchronous

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Synchronous

Time Frame: 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

Time Frame: 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 Outcomes

  • All-cause mortality(up to 30 years)
  • Associations with treatment choice(up to 30 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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