Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
NCT ID: NCT04257084
Last Updated: 2020-11-24
Study Results
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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UNKNOWN
NA
188 participants
INTERVENTIONAL
2020-12-31
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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CE-NBI
High definition chromoendoscopy with target biopsy, at 1st surveillance colonoscopy during the trial High definition NBI with target biopsy, at 2nd surveillance colonoscopy during the trial
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.
NBI-CE
High definition NBI with target biopsy, at 1st surveillance colonoscopy during the trial High definition chromoendoscopy with target biopsy, at 2nd surveillance colonoscopy during the trial
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. A patient having extensive ulcerative colitis with 8-year or longer disease duration
2. A patient having both ulcerative colitis and primary sclerosing colitis
3. A patient having a previous history of dysplasia at the colitic segment within recent 5 years
Exclusion Criteria
1. A patient who underwent total or segment colectomy.
2. A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk
3. A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months
4. A patient who has a coagulopathy
5. A patient who has chronic renal disease evidenced by serum creatinine \> 1.2 mg/dL within 6 months of study participation
6. A patient who has already undergone surveillance colonoscopy within 1 year
* All of the following conditions should be excluded for 2nd surveillance colonoscopy study even if they were included in 1st surveillance study.
1. A patient who underwent total or segment colectomy after 1st surveillance colonoscopy for this trial.
2. A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk
3. A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months
4. A patient who has a coagulopathy
5. A patient who has chronic renal disease evidenced by serum creatinine \> 1.2 mg/dL within 6 months of study participation
19 Years
79 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Samsung Medical Center
OTHER
Sungkyunkwan University
OTHER
Ewha Womans University
OTHER
The Catholic University of Korea
OTHER
Soonchunhyang University Hospital
OTHER
Asan Medical Center
OTHER
Responsible Party
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Dong-Hoon Yang
Clinical Associate Professor
Principal Investigators
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Dong-Hoon Yang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Central Contacts
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Other Identifiers
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SUNRISE-High
Identifier Type: -
Identifier Source: org_study_id