Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions (ACID-SSL)

May 17, 2026 updated by: Zhaoshen Li, Changhai Hospital

Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions: a Multicenter Randomized Trial

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2689

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • China, Shanghai Changhai Hospital, Second Military Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients whose age are between 45-85
  • Patients who have indications for screening
  • Patients who have signed inform consent form.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetic Acid-Indigo Carmine Chromocolonoscopy Group
Procedure: 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.
Sham Comparator: Brilliant Blue Chromocolonoscopy Sham-Control Group
Procedure: 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.
No Intervention: Conventional White-Light Colonoscopy Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proximal SSL Detection Rate
Time Frame: 60 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal precancerous lesions detection rate
Time Frame: 60 minutes
The proportion of participants with at least one histologically confirmed precancerous lesion (adenoma, or SSL) detected during withdrawal examination.
60 minutes
Adenoma Detection Rate
Time Frame: 60 minutes
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.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

The First Affiliated Hospital of Nanchang University
The Second Hospital of Hebei Medical University
Ankang Central Hospital
Shanxi Provincial People's Hospital
Chongqing General Hospital
Yan'an People's Hospital
The Third People's Hospital of Chengdu
Heilongjiang Provicial Hospital
People's Hospital of Leshan, Sichuan Province
Huadong Hospital Affiliated with Fudan University, Shanghai
The Third People's Hospital of Jingdezhen
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Shanghai Sixth Hospital
Ningbo Hospital of Integrated Traditional Chinese and Western Medicine
Shandong Provincial Second People's Hospital

Investigators

  • Principal Investigator: Zhaoshen Li, MD, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

November 15, 2028

Study Completion (Estimated)

November 15, 2028

Study Registration Dates

First Submitted

May 17, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHSSLDR202602

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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