Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate

NCT06961149 | Recruiting

• 1 other identifier: KYLL-202502-013-1
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Indigo carmine spraying up to the colonic mucosa could probably increase the adenoma detection rate, but considering the long withdrawal time of the endoscope and the resulting increase in time and cost. Linked-color imaging (LCI) is a newly developed image-enhanced endoscopy technology. It relies on wave length optimization of three colors (red, green, and blue) to make the lesions appear fuller. LCI improves the visibility of colorectal adenomas and polyps and may increase the detection rate of lesions. In order to explore the clinical application value of Linked-color imaging endoscopy, we performed a prospective, randomized controlled trial to compare adenoma detection rate of Linked-color imaging endoscopy and indigo carmine chromoendoscopy.

Conditions

Colonic Polyps; Adenomatous Polyps; Adenoma Detection Rate; Chromoendoscopy; Colorectal Neoplasms

Keywords

Adenoma Detection Rate; Linked-color imaging; Chromoendoscopy; Colonoscopy; Indigo Carmine

Outcome Measures

Primary Outcomes (1)

• adenoma detection rate(ADR)

  adenoma detection rate (ADR) defined as the percentage of patients with at least one histologically confirmed adenomatous polyp detected and resected during colonoscopy.

  Periprocedural

Secondary Outcomes (1)

• detected rate of different lesions

  Periprocedural

Study Arms (2)

Linked-color imaging endoscopy

EXPERIMENTAL

Patients in this group will be carefully observed with LCI endoscopy during the colonoscopy withdraw.

Procedure: Linked-color imaging endoscopy

Chromoendoscopy with indigo carmine solution spray

ACTIVE COMPARATOR

Patients in this group will be carefully observed with spraying indigo carmine solution during the colonoscopy withdraw.

Procedure: Chromoendoscopy with indigo carmine solution spray

Interventions

Chromoendoscopy with indigo carmine solution spray PROCEDURE

Patients will undergo chromoendoscopy with spraying indigo carmine.

Chromoendoscopy with indigo carmine solution spray

Linked-color imaging endoscopy PROCEDURE

Patients will undergo Linked-color imaging endoscopy.

Linked-color imaging endoscopy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 45 and 85 years
• Patients with a history of colorectal adenoma
• Patients whose first-degree relatives have a history of colorectal cancer or colorectal adenoma
• Patients with gastrointestinal symptoms (abdominal pain, bloody stool, chronic diarrhea or constipation, Unexplained anemia or weight loss;
• Patients with positive Fecal Immunochemical Test

You may not qualify if:

• Patients with pregnancy, inflammatory bowel disease, familial adenomatosis polyposis, suspected CRC; intestinal obstruction, coagulopathy
• Patients with aspirin, clopidogrel or other anticoagulants/ antiplatelet drugs intake within 7 days
• Patents previous colorectal resection
• Patients with failed cecal intubation
• Patients with inadequate bowel preparation quality (BBPS≤5)
• Patients who refuse to participate or to provide informed consent

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Adenomatous Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Rui Ji MD PHD

CONTACT

+86-18560086103; qljirui@email.sdu.edu.cn

Rui Ji MD PHD, +86-18560086103

CONTACT

qljirui@email.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 7, 2025
• Study Start: April 8, 2025
• Primary Completion: January 31, 2026
• Study Completion: April 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)