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NOT YET RECRUITING
NCT07601217
NA

Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

Summary

Chromocolonoscopy with acetic acid and indigo carmine has shown promise for improving the detection of sessile serrated lesions (SSLs), the precursor lesions responsible for a substantial proportion of interval colorectal cancers. Previous studies have demonstrated its potential to enhance visualization of both adenomatous and non-adenomatous polyps, particularly the subtle SSLs that are frequently missed during conventional white-light colonoscopy. However, high-quality randomized controlled trials comparing chromocolonoscopy with standard white-light imaging to provide definitive evidence on its efficacy for SSL detection are lacking. We therefore conducted a multicenter, prospective, randomized controlled trial to evaluate the diagnostic yield of acetic acid-indigo carmine chromocolonoscopy versus standard colonoscopy for SSL detection.

Official title: Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions: a Multicenter Randomized Trial

Key Details

Gender

All

Age Range

45 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

2689

Start Date

2026-06-15

Completion Date

2028-11-15

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

PROCEDURE

Acetic Acid-Indigo Carmine Chromocolonoscopy Group

Participants undergo colonoscopy with acetic acid-indigo carmine chromoendoscopy. After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.

PROCEDURE

Brilliant Blue Chromocolonoscopy Sham-Control Group

Participants undergo colonoscopy with brilliant blue dye application as a sham chromoendoscopy control to maintain participant blinding. After cecal intubation and randomization, an opaque brilliant blue solution is sprayed from the cecum to the splenic flexure using a spray catheter, with suctioning of any excess dye.

Locations (1)

China, Shanghai Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China