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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ulcerative Colitis; Dysplasia
• Intervention / Treatment: Diagnostic test: chromoendoscopy with target biopsy; NBI with target biopsy

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong-Hoon Yang, MD, PhD; Phone Number: 82-2-3010-5809; Email: dhyang@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Diagnostic test: 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.
Active Comparator: 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	Diagnostic test: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Samsung Medical Center; Yonsei University; Ewha Womans University; The Catholic University of Korea; Soonchunhyang University Hospital; Sungkyunkwan University
• Investigators: Principal Investigator: Dong-Hoon Yang, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: surveillance; chromoendoscopy; narrow band image
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: SUNRISE-High

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No