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

NCT ID: NCT06961149

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2026-04-01

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.

Detailed Description

If patients scheduled for colonoscopy meet the inclusion criteria but not the exclusion criteria, participants will be recruited to the study and randomized to one of two groups. Group allocation was revealed to endoscopists upon confirmation of cecal intubation. participants in Group A (treatment group) will undergo colonoscopy with LCI. participants in Group B (control group) will undergo spraying indigo carmine solution during withdrawal process. Any lesions found during the procedure will be removed and sent for pathological examination. The investigator will record the participants' general information (such as gender, age, symptoms, body mass index，etc.), colonoscopy data (such as duration etc.), and lesion characteristics (such as location, morphology, histopathological classification, etc.). All data were analyzed according to the ITT analysis, and the PP analysis was performed for all outcomes. Continuous variables were presented as means ± standard deviation (SD), and compared using Independent Samples t test. Categorical variables were expressed as frequency counts (percentages) and analyzed using Pearson's chi-square test or the Fisher exact test. Statistical analyses were performed using SPSS 27.0. Statistical significance was defined as P < 0.05.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Linked-color imaging endoscopy

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

Group Type: EXPERIMENTAL

Linked-color imaging endoscopy

Intervention Type: PROCEDURE

Patients will undergo Linked-color imaging endoscopy.

Chromoendoscopy with indigo carmine solution spray

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

Group Type: ACTIVE_COMPARATOR

Chromoendoscopy with indigo carmine solution spray

Intervention Type: PROCEDURE

Patients will undergo chromoendoscopy with spraying indigo carmine.

Interventions

Chromoendoscopy with indigo carmine solution spray

Patients will undergo chromoendoscopy with spraying indigo carmine.

Intervention Type: PROCEDURE

Linked-color imaging endoscopy

Patients will undergo Linked-color imaging endoscopy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age between 45 and 85 years

2. Patients with a history of colorectal adenoma

3. Patients whose first-degree relatives have a history of colorectal cancer or colorectal adenoma

4. Patients with gastrointestinal symptoms (abdominal pain, bloody stool, chronic diarrhea or constipation, Unexplained anemia or weight loss;

5. Patients with positive Fecal Immunochemical Test

Exclusion Criteria

1. Patients with pregnancy, inflammatory bowel disease, familial adenomatosis polyposis, suspected CRC; intestinal obstruction, coagulopathy

2. Patients with aspirin, clopidogrel or other anticoagulants/ antiplatelet drugs intake within 7 days

3. Patents previous colorectal resection

4. Patients with failed cecal intubation

5. Patients with inadequate bowel preparation quality (BBPS≤5)

6. Patients who refuse to participate or to provide informed consent

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Ji MD PHD

Role: CONTACT

qljirui@email.sdu.edu.cn

+86-18560086103

Rui Ji MD PHD, +86-18560086103

Role: CONTACT

qljirui@email.sdu.edu.cn

Facility Contacts

Rui Ji MD PHD

Role: primary

qljirui@email.sdu.edu.cn

+86-18560086103

Other Identifiers

KYLL-202502-013-1

Identifier Type: -

Identifier Source: org_study_id