Clinical Research Directory
Browse clinical research sites, groups, and studies.
Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions
Sponsor: Changhai Hospital
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
Conditions
Interventions
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 After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.
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