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

Shandong University

Status: Enrolling

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

Treatments: Procedure: Linked-color imaging endoscopy; Procedure: Chromoendoscopy with indigo carmine solution spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06961149

KYLL-202502-013-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 352 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

Linked-color imaging endoscopy

Experimental group

Description:

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

Treatment:

Procedure: Linked-color imaging endoscopy

Chromoendoscopy with indigo carmine solution spray

Active Comparator group

Description:

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

Treatment:

Procedure: Chromoendoscopy with indigo carmine solution spray