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

Ulcerative Colitis Clinical Trial

— SUNRISE-High  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04257084
• Other study ID #: SUNRISE-High
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: January 2023

Study information

• Verified date: November 2020
• Source: Asan Medical Center
• Contact: Dong-Hoon Yang, MD, PhD
• Phone: 82-2-3010-5809
• Email: dhyang[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 188
• Est. completion date: January 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Dysplasia
• Ulcer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Asan Medical Center	Ewha Womans University, Samsung Medical Center, Soonchunhyang University Hospital, Sungkyunkwan University, The Catholic University of Korea, Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Total procedure time	The whole colonoscopy procedure time	3 months after overall surveillance colonoscopy in each arm
Secondary	Withdrawal time	Time spent for withdrawal after excluding time for taking biopsies	3 months after overall surveillance colonoscopy in each arm
Secondary	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
Secondary	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