Trials / Unknown
UnknownNCT04257084
Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
A Multicenter, Randomized Controlled Trial for Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- Sponsor
- Asan Medical Center · Academic / Other
- Sex
- All
- Age
- 19 Years – 79 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2022-08-01
- Completion
- 2023-01-01
- First posted
- 2020-02-05
- Last updated
- 2020-11-24
Source: ClinicalTrials.gov record NCT04257084. Inclusion in this directory is not an endorsement.