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.
Patients whose age are between 45-85
Patients who have indications for screening
Patients who have signed inform consent form.
Patients undergoing surveillance colonoscopy after polypectomy or therapeutic colonoscopy for known polyps
Patients with a history of colonoscopy within the past 5 years
Patients with highly suspected or confirmed colorectal cancer
Patients with alarming signs or symptoms: hematochezia, melena, unexplained anemia, weight loss, abdominal mass, positive digital rectal examination
Parallel
Acetic Acid-Indigo Carmine Chromocolonoscopy Group
Procedure/SurgeryParticipants 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 After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.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
Procedure/SurgeryParticipants 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.
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.
Colorectal precancerous lesions detection rate
The proportion of participants with at least one histologically confirmed precancerous lesion (adenoma, or SSL) detected during withdrawal examination.
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.
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Changhai Hospital
Lead sponsor
Heilongjiang Provicial Hospital
Collaborator
Ankang Central Hospital
Collaborator
Huadong Hospital Affiliated with Fudan University, Shanghai
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Yan'an People's Hospital
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Chongqing General Hospital
Collaborator
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Collaborator
Shanxi Provincial People's Hospital
Collaborator
Shanghai Sixth Hospital
Collaborator
People's Hospital of Leshan, Sichuan Province
Collaborator
The Third People's Hospital of Chengdu
Collaborator
The Third People's Hospital of Jingdezhen
Collaborator
Ningbo Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
Shandong Provincial Second People's Hospital
Collaborator
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