Clinical trial NCT06961149: Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate
Official title: Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate: a Prospective , Randomized Controlled, Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Polyps
Adenomatous Polyps
Adenoma Detection Rate
Chromoendoscopy
Colorectal Neoplasms
Keywords: Adenoma Detection Rate
Linked-color imaging
Chromoendoscopy
Colonoscopy
Indigo Carmine
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 352
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: adenoma detection rate(ADR)
timeFrame: Periprocedural
Secondary outcomes:
measure: detected rate of different lesions
timeFrame: Periprocedural
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: