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

NCT04257084 | Unknown

• 1 other identifier: SUNRISE-High
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis; Dysplasia

Keywords

chromoendoscopy; narrow band image; surveillance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• SSL detection rate

  3 months after overall surveillance colonoscopy in each arm

• Total procedure time

  3 months after overall surveillance colonoscopy in each arm

• Withdrawal time

  3 months after overall surveillance colonoscopy in each arm

• Endoscopic features of target-biopsied lesions

  3 months after overall surveillance colonoscopy in each arm

• Procedure-related adverse events

  3 months after overall surveillance colonoscopy in each arm

Study Arms (2)

CE-NBI

ACTIVE COMPARATOR

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

NBI-CE

ACTIVE COMPARATOR

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

Interventions

chromoendoscopy with target biopsy; NBI with target biopsy DIAGNOSTIC_TEST

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.

CE-NBI; NBI-CE

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Yonsei University: collaborator
• Samsung Medical Center: collaborator
• Sungkyunkwan University: collaborator
• Ewha Womans University: collaborator
• The Catholic University of Korea: collaborator
• Soonchunhyang University Hospital: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dong-Hoon Yang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Hoon Yang, MD, PhD

CONTACT

82-2-3010-5809; dhyang@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: a randomized controlled crossover trial

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 5, 2020
• Study Start: December 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: January 1, 2023
• Last Updated: November 24, 2020

Record last verified: 2020-11