Clinical trial NCT04257084: Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
Official title: A Multicenter, Randomized Controlled Trial for Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Dysplasia
Keywords: chromoendoscopy
narrow band image
surveillance
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Yonsei University
name: Samsung Medical Center
name: Sungkyunkwan University
name: Ewha Womans University
name: The Catholic University of Korea
name: Soonchunhyang University Hospital
First posted: 2020-02-05
Enrollment: 188
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a randomized controlled crossover trial
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dysplasia detection rate at first surveillance
timeFrame: 3 months after first surveillance colonoscopy in each arm
measure: Neoplasia detection rate at first surveillance
timeFrame: 3 months after first surveillance colonoscopy in each arm
measure: Dysplasia detection rate at second surveillance
timeFrame: 3 months after second surveillance colonoscopy in each arm
measure: Neoplasia detection rate at second surveillance
timeFrame: 3 months after second surveillance colonoscopy in each arm
Secondary outcomes:
measure: SSL detection rate
timeFrame: 3 months after overall surveillance colonoscopy in each arm
measure: Total procedure time
timeFrame: 3 months after overall surveillance colonoscopy in each arm
measure: Withdrawal time
timeFrame: 3 months after overall surveillance colonoscopy in each arm
measure: Endoscopic features of target-biopsied lesions
timeFrame: 3 months after overall surveillance colonoscopy in each arm
measure: Procedure-related adverse events
timeFrame: 3 months after overall surveillance colonoscopy in each arm
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Dong-Hoon Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: