Treatment Outcomes of Advanced Neoplasia in IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05674773
• Other study ID #: 2017-3219
• Status: Active, not recruiting
• Start date: May 21, 2019
• Est. completion date: July 1, 2023

Study information

• Verified date: December 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 189
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Procedure:
• Endoscopic or surgical resection
endoscopic or surgical (partial, (sub)total, proctocolectomy) resection

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (7)

Lead Sponsor	Collaborator
Radboud University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, Erasmus Medical Center, Jeroen Bosch Ziekenhuis, Rijnstate Hospital, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Synchronous	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	up to 6 months
Primary	Metachronous (advanced) neoplasia	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	up to 30 years
Secondary	All-cause mortality	All-cause mortality	up to 30 years
Secondary	Associations with treatment choice	Clinical and disease characteristics associated with AN treatment choice	up to 30 years