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

Primary Purpose

Ulcerative Colitis, Dysplasia

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

chromoendoscopy with target biopsy; NBI with target biopsy

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring chromoendoscopy, narrow band image, surveillance

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CE-NBI

NBI-CE

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

Dysplasia detection rate at second surveillance

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

Secondary Outcome Measures

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.

Total procedure time

The whole colonoscopy procedure time

Withdrawal time

Time spent for withdrawal after excluding time for taking biopsies

Endoscopic features of target-biopsied lesions

Pit and vascular patterns, Modified Paris classification (suggested by SCENIC group)

Procedure-related adverse events

bleeding requiring hemostasis or transfusion, perforation, exacerbation of UC requiring admission (within 3 months after surveillance colonoscopy)

Full Information

NCT ID

NCT04257084

First Posted

February 2, 2020

Last Updated

November 23, 2020

Sponsor

Asan Medical Center

Collaborators

Yonsei University, Samsung Medical Center, Sungkyunkwan University, Ewha Womans University, The Catholic University of Korea, Soonchunhyang University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04257084

Brief Title

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

Acronym

SUNRISE-High

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

Collaborators

Yonsei University, Samsung Medical Center, Sungkyunkwan University, Ewha Womans University, The Catholic University of Korea, Soonchunhyang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Dysplasia

Keywords

chromoendoscopy, narrow band image, surveillance

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

a randomized controlled crossover trial

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CE-NBI

Arm Type

Active Comparator

Arm Description

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

Arm Title

NBI-CE

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

chromoendoscopy with target biopsy; NBI with target biopsy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dysplasia detection rate at first surveillance

Description

Time Frame

3 months after first surveillance colonoscopy in each arm

Title

Neoplasia detection rate at first surveillance

Description

Neoplasia at any segments (regardless of colitis) will be counted as "neoplasia" to calculate neoplasia detection rate. SSL will be counted as neoplasia

Time Frame

3 months after first surveillance colonoscopy in each arm

Title

Dysplasia detection rate at second surveillance

Description

Time Frame

3 months after second surveillance colonoscopy in each arm

Title

Neoplasia detection rate at second surveillance

Description

Neoplasia at any segments (regardless of colitis) will be counted as "neoplasia" to calculate neoplasia detection rate. SSL will be counted as neoplasia

Time Frame

3 months after second surveillance colonoscopy in each arm

Secondary Outcome Measure Information:

Title

SSL detection rate

Description

Time Frame