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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized Controlled Trial for Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups

Conditions
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Ulcerative Colitis, Dysplasia

Intervention / Treatment
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* Diagnostic Test: chromoendoscopy with target biopsy; NBI with target biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one of the followings should be satisfied; A patient having extensive ulcerative colitis with 8-year or longer disease duration A patient having both ulcerative colitis and primary sclerosing colitis A patient having a previous history of dysplasia at the colitic segment within recent 5 years Exclusion Criteria: All of the following conditions should be excluded for 1st surveillance colonoscopy study A patient who underwent total or segment colectomy. A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months A patient who has a coagulopathy A patient who has chronic renal disease evidenced by serum creatinine > 1.2 mg/dL within 6 months of study participation 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. A patient who underwent total or segment colectomy after 1st surveillance colonoscopy for this trial. A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months A patient who has a coagulopathy A patient who has chronic renal disease evidenced by serum creatinine > 1.2 mg/dL within 6 months of study participation

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: a randomized controlled crossover trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CE-NBI<br>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 | Diagnostic Test: chromoendoscopy with target biopsy; NBI with target biopsy<br>* 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.<br>|
| Active Comparator: NBI-CE<br>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 | Diagnostic Test: chromoendoscopy with target biopsy; NBI with target biopsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysplasia detection rate at first surveillance | Any dysplasia within the colitic segments will be counted as dysplasia to calculate dysplasia detection rate. A sessile serrated lesion (SSL) with dysplasia located in the colitic segment will be counted as dysplasia, but SSLs without dysplasia will not be counted as dysplasia even if located within colitic segments. | 3 months after first surveillance colonoscopy in each arm | 
| Neoplasia detection rate at first surveillance | Neoplasia at any segments (regardless of colitis) will be counted as neoplasia to calculate neoplasia detection rate. SSL will be counted as neoplasia | 3 months after first surveillance colonoscopy in each arm | 
| Dysplasia detection rate at second surveillance | Any dysplasia within the colitic segments will be counted as dysplasia to calculate dysplasia detection rate. A sessile serrated lesion (SSL) with dysplasia located in the colitic segment will be counted as dysplasia, but SSLs without dysplasia will not be counted as dysplasia even if located within colitic segments. | 3 months after second surveillance colonoscopy in each arm | 
| Neoplasia detection rate at second surveillance | Neoplasia at any segments (regardless of colitis) will be counted as neoplasia to calculate neoplasia detection rate. SSL will be counted as neoplasia | 3 months after second surveillance colonoscopy in each arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSL detection rate | Whether located at colitic or non-colitic segments, SSL will be included for calculating SSL detection rate in each arm. Serrated epithelial changes (serrated epithelial changes in histology, but nor discrete border under colonoscopy or no dysplasia under microscopy) will not be considered as SSL. | 3 months after overall surveillance colonoscopy in each arm | 
| Total procedure time | The whole colonoscopy procedure time | 3 months after overall surveillance colonoscopy in each arm | 
| Withdrawal time | Time spent for withdrawal after excluding time for taking biopsies | 3 months after overall surveillance colonoscopy in each arm | 
| Endoscopic features of target-biopsied lesions | Pit and vascular patterns, Modified Paris classification (suggested by SCENIC group) | 3 months after overall surveillance colonoscopy in each arm | 
| Procedure-related adverse events | bleeding requiring hemostasis or transfusion, perforation, exacerbation of UC requiring admission (within 3 months after surveillance colonoscopy) | 3 months after overall surveillance colonoscopy in each arm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chromoendoscopy, narrow band image, surveillance