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NCT Number: NCT07601217

Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions

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.

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Key information

Conditions

Sessile Serrated Lesion

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetic Acid-Indigo Carmine Chromocolonoscopy Group

Procedure

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.

Brilliant Blue Chromocolonoscopy Sham-Control Group

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Bai, MD

CONTACT

[email protected]

86-021-31161335

Zhaoshen Li, MD

CONTACT

[email protected]

86-021-31161365

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ACID-SSL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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