Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups

NCT04257084 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2020-11-24

No results posted yet for this study

Summary

The risk of colorectal cancer (CRC) is increased in patients having ulcerative colitis (UC). Patients with long-standing extensive colitis, concomitant primary sclerosing cholangitis, or previous history of dysplasia carry an exceptionally high risk of CRC and require regular and short-interval surveillance colonoscopy. Recent guidelines recommend surveillance colonoscopy based on target biopsy rather than random biopsy applying chromoendoscopy (CE) or narrow band image (NBI) technique in UC at risk for CRC. However, the diagnostic yield of NBI-based surveillance and CE-based surveillance is not extensively investigated in the high-risk UC population. The investigators aimed to compare the dysplasia detection rate of NBI with that of CE in UC patients with a high risk of CRC by performing a multicenter, randomized controlled trial.

Conditions

Interventions

DIAGNOSTIC_TEST

chromoendoscopy with target biopsy; NBI with target biopsy

Chromoendoscopy with target biopsy: 0.03% indigo carmine solution based chromoendoscopy (using high-definition colonoscopy) will be fulfilled and target biopsies will be taken at all abnormal mucosal lesions suspected dysplasia/neoplasia. NBI with target biopsy: After inserting a high definition colonoscopy up to cecum, endoscopists observe the colon in combination of white light and NBI (white light first and then NBI). Target biopsies will be taken at all abnormal mucosal lesions suspected dysplasia/neoplasia.

Sponsors & Collaborators

  • Yonsei University

    collaborator OTHER
  • Samsung Medical Center

    collaborator OTHER
  • Sungkyunkwan University

    collaborator OTHER
  • Ewha Womans University

    collaborator OTHER
  • The Catholic University of Korea

    collaborator OTHER
  • Soonchunhyang University Hospital

    collaborator OTHER
  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Dong-Hoon Yang, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2022-08-31
Completion
2023-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257084 on ClinicalTrials.gov