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

Not Applicable

• Conditions: Dysplasia; Ulcerative Colitis
• Interventions: Diagnostic Test: chromoendoscopy with target biopsy; NBI with target biopsy

• Registration Number: NCT04257084
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24
• Study Start: 2020-12
• Primary Completion: 2022-08
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CE-NBI	chromoendoscopy with target biopsy; NBI with target biopsy	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
NBI-CE	chromoendoscopy with target biopsy; NBI with target biopsy	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

Primary Outcome Measures

Name	Time	Method
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 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.
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 Outcome Measures

Name	Time	Method
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.
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)
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)