Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions
Starting soon · Not applicable · Has a placebo group
Conditions studied: Sessile Serrated Lesion
In brief
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.
Key facts
- Study ID
- NCT07601217
- Run by
- Changhai Hospital
- People needed
- 2689
- Starts
- 2026-06-15
- Expected to finish
- 2028-11-15
- Last updated by the study team
- 2026-05-22
Who can join
Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients whose age are between 45-85
- Patients who have indications for screening
- Patients who have signed inform consent form.
You may not qualify if…
- 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
- Pregnant or breastfeeding women
- Patients with gastrointestinal obstruction
- Patients with inflammatory bowel disease, colonic polyposis, or melanosis coli
- Patients with coagulation disorders or who have taken antiplatelets or anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy
- Patients currently participating in another clinical trial or who have participated in another clinical trial within the preceding 60 days
- Patients with failed cecal intubation for any reason (e.g., obstructing lesion, intolerance of the procedure)
- Patients with an Aronchick bowel preparation score >3 at colonoscope insertion, indicating inadequate preparation requiring a repeat bowel preparation
- Patients who have used bowel preparation agents not recommended by guidelines, such as oral sodium phosphate or senna
- Patients with known allergy to acetic acid-indigo carmine, brilliant blue dye, or medications related to colonoscopy
- Patients with missing essential information in the case report form prior to enrollment
Where it is running
- China, Shanghai Changhai Hospital, Second Military Medical University — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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