Treatment Outcomes of Advanced Neoplasia in IBD

NCT ID: NCT05674773

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-21

Study Completion Date

2023-07-01

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IBD patients with advanced neoplasia

IBD patients with advanced neoplasia (high-grade dysplasia or colorectal cancer) treated with:

* proctocolectomy
* (sub)total colectomy
* partial colectomy
* endoscopic resection

Endoscopic or surgical resection

Intervention Type PROCEDURE

endoscopic or surgical (partial, (sub)total, proctocolectomy) resection

Interventions

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Endoscopic or surgical resection

endoscopic or surgical (partial, (sub)total, proctocolectomy) resection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role collaborator

Jeroen Bosch Ziekenhuis

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Hoentjen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboudumc and University of Alberta

Locations

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Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2017-3219

Identifier Type: -

Identifier Source: org_study_id

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