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

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.

Conditions

• Sessile Serrated Lesion

Interventions

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.

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 After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.

Sponsors & Collaborators

• Heilongjiang Provicial Hospital

  collaborator OTHER

• Ankang Central Hospital

  collaborator OTHER

• Huadong Hospital Affiliated with Fudan University, Shanghai

  collaborator UNKNOWN

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Yan'an People's Hospital

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Chongqing General Hospital

  collaborator OTHER

• Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)

  collaborator UNKNOWN

• Shanxi Provincial People's Hospital

  collaborator OTHER_GOV

• Shanghai Sixth Hospital

  collaborator UNKNOWN

• People's Hospital of Leshan, Sichuan Province

  collaborator UNKNOWN

• The Third People's Hospital of Chengdu

  collaborator OTHER

• The Third People's Hospital of Jingdezhen

  collaborator UNKNOWN

• Ningbo Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator UNKNOWN

• Shandong Provincial Second People's Hospital

  collaborator UNKNOWN

• Changhai Hospital

  lead OTHER

Principal Investigators

• Zhaoshen Li, MD · Changhai Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-15

Primary Completion

2028-11-15

Completion

2028-11-15

Countries

• China

Study Locations