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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorChanghai Hospital

About this 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.

Eligibility criteria

Qualifiers

Patients whose age are between 45-85

Patients who have indications for screening

Patients who have signed inform consent form.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Acetic Acid-Indigo Carmine Chromocolonoscopy Group
  • Brilliant Blue Chromocolonoscopy Sham-Control Group

Treatment groups

2,689 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Changhai Hospital

Lead sponsor

Heilongjiang Provicial Hospital

Collaborator

Ankang Central Hospital

Collaborator

Huadong Hospital Affiliated with Fudan University, Shanghai

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Yan'an People's Hospital

Collaborator

The Second Hospital of Hebei Medical University

Collaborator

Chongqing General Hospital

Collaborator

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

Collaborator

Shanxi Provincial People's Hospital

Collaborator

Shanghai Sixth Hospital

Collaborator

People's Hospital of Leshan, Sichuan Province

Collaborator

The Third People's Hospital of Chengdu

Collaborator

The Third People's Hospital of Jingdezhen

Collaborator

Ningbo Hospital of Integrated Traditional Chinese and Western Medicine

Collaborator

Shandong Provincial Second People's Hospital

Collaborator