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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
2,689
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 After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.
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.
China, Shanghai Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China
Proximal SSL Detection Rate
The proportion of participants with at least one histologically confirmed sessile serrated lesion detected in the proximal colon (cecum, ascending colon, hepatic flexure, transverse colon, and splenic flexure) during withdrawal examination.
Time frame: 60 minutes
Colorectal precancerous lesions detection rate
The proportion of participants with at least one histologically confirmed precancerous lesion (adenoma, or SSL) detected during withdrawal examination.
Time frame: 60 minutes
Adenoma Detection Rate
The proportion of participants with at least one histologically confirmed adenoma (tubular, villous, or tubulovillous) detected during withdrawal examination, compared across all three study groups.
Time frame: 60 minutes
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