Dysplasia, Ulcerative Colitis
Conditions
Keywords
chromoendoscopy, narrow band image, surveillance
Brief 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.
Interventions
DIAGNOSTIC_TESTchromoendoscopy 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
Yonsei University
Samsung Medical Center
Sungkyunkwan University
Ewha Womans University
The Catholic University of Korea
Soonchunhyang University Hospital
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
a randomized controlled crossover trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* At least one of the followings should be satisfied; 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
* All of the following conditions should be excluded for 1st surveillance colonoscopy study 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neoplasia detection rate at first surveillance | 3 months after first surveillance colonoscopy in each arm | Neoplasia at any segments (regardless of colitis) will be counted as neoplasia to calculate neoplasia detection rate. SSL will be counted as neoplasia |
| Dysplasia detection rate at second surveillance | 3 months after second surveillance colonoscopy in each arm | 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. |
| Dysplasia detection rate at first surveillance | 3 months after first surveillance colonoscopy in each arm | 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. |
| Neoplasia detection rate at second surveillance | 3 months after second surveillance colonoscopy in each arm | Neoplasia at any segments (regardless of colitis) will be counted as neoplasia to calculate neoplasia detection rate. SSL will be counted as neoplasia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SSL detection rate | 3 months after overall surveillance colonoscopy in each arm | 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. |
| Procedure-related adverse events | 3 months after overall surveillance colonoscopy in each arm | bleeding requiring hemostasis or transfusion, perforation, exacerbation of UC requiring admission (within 3 months after surveillance colonoscopy) |
| Total procedure time | 3 months after overall surveillance colonoscopy in each arm | The whole colonoscopy procedure time |
| Withdrawal time | 3 months after overall surveillance colonoscopy in each arm | Time spent for withdrawal after excluding time for taking biopsies |
| Endoscopic features of target-biopsied lesions | 3 months after overall surveillance colonoscopy in each arm | Pit and vascular patterns, Modified Paris classification (suggested by SCENIC group) |
Contacts
Primary ContactDong-Hoon Yang, MD, PhD
Outcome results
None listed