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NCT Number: NCT06961149

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Chromoendoscopy with indigo carmine solution spray

Procedure

Patients will undergo chromoendoscopy with spraying indigo carmine.

Linked-color imaging endoscopy

Procedure

Patients will undergo Linked-color imaging endoscopy.

Primary outcomes

  1. adenoma detection rate(ADR)

    Time frame: Periprocedural

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

Secondary outcomes

  1. detected rate of different lesions

    Time frame: Periprocedural

    detected rate of different lesions(advanced adenoma, sessile serrated lesion) adenoma per colonoscopy (APC) withdrawal time adverse event rates

Study contacts

Contact information is provided by the study sponsor or research team.

Rui Ji MD PHD

CONTACT

[email protected]

+86-18560086103

Rui Ji MD PHD, +86-18560086103

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate: a Prospective , Randomized Controlled, Non-inferiority Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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