Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions
ACID-SSL
1 other identifier
interventional
2,689
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2028
Study Completion
Last participant's last visit for all outcomes
November 15, 2028
May 22, 2026
May 1, 2026
2.4 years
May 17, 2026
May 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
60 minutes
Secondary Outcomes (2)
Colorectal precancerous lesions detection rate
60 minutes
Adenoma Detection Rate
60 minutes
Study Arms (3)
Acetic Acid-Indigo Carmine Chromocolonoscopy Group
EXPERIMENTALBrilliant Blue Chromocolonoscopy Sham-Control Group
SHAM COMPARATORConventional White-Light Colonoscopy Group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- Heilongjiang Provicial Hospitalcollaborator
- Ankang Central Hospitalcollaborator
- Huadong Hospital Affiliated with Fudan University, Shanghaicollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Yan'an People's Hospitalcollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- Chongqing General Hospitalcollaborator
- Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)collaborator
- Shanxi Provincial People's Hospitalcollaborator
- Shanghai Sixth Hospitalcollaborator
- People's Hospital of Leshan, Sichuan Provincecollaborator
- The Third People's Hospital of Chengducollaborator
- The Third People's Hospital of Jingdezhencollaborator
- Ningbo Hospital of Integrated Traditional Chinese and Western Medicinecollaborator
- Shandong Provincial Second People's Hospitalcollaborator
Study Sites (1)
China, Shanghai Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200433, China
Related Publications (3)
Crockett SD, Nagtegaal ID. Terminology, Molecular Features, Epidemiology, and Management of Serrated Colorectal Neoplasia. Gastroenterology. 2019 Oct;157(4):949-966.e4. doi: 10.1053/j.gastro.2019.06.041. Epub 2019 Jul 16.
PMID: 31323292RESULTKinugasa H, Hiraoka S, Kobayashi S, Matsubara M, Nagahara T, Higashi R, Takei K, Ohmori M, Nakamura T, Tsuzuki T, Tanaka S, Hirai R, Toyosawa J, Aoyama Y, Yamasaki Y, Inokuchi T, Takahara M, Tanaka T, Mitsuhashi T, Otsuka M; cAIM Study Group. Acetic Acid-Indigo Carmine Chromocolonoscopy for Proximal Serrated Lesions: A Randomized, 3-Arm Colonoscopy Study. Am J Gastroenterol. 2025 Dec 1;120(12):2877-2888. doi: 10.14309/ajg.0000000000003411. Epub 2025 Mar 13.
PMID: 40079452RESULTSung JJY, Chiu HM, Lieberman D, Kuipers EJ, Rutter MD, Macrae F, Yeoh KG, Ang TL, Chong VH, John S, Li J, Wu K, Ng SSM, Makharia GK, Abdullah M, Kobayashi N, Sekiguchi M, Byeon JS, Kim HS, Parry S, Cabral-Prodigalidad PAI, Wu DC, Khomvilai S, Lui RN, Wong S, Lin YM, Dekker E. Third Asia-Pacific consensus recommendations on colorectal cancer screening and postpolypectomy surveillance. Gut. 2022 Nov;71(11):2152-2166. doi: 10.1136/gutjnl-2022-327377. Epub 2022 Aug 24.
PMID: 36002247RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaoshen Li, MD
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Study Record Dates
First Submitted
May 17, 2026
First Posted
May 22, 2026
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
November 15, 2028
Study Completion (Estimated)
November 15, 2028
Last Updated
May 22, 2026
Record last verified: 2026-05