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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorShandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chromoendoscopy with indigo carmine solution spray

    Procedure/Surgery

    Patients will undergo chromoendoscopy with spraying indigo carmine.

  • Linked-color imaging endoscopy

    Procedure/Surgery

    Patients will undergo Linked-color imaging endoscopy.

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: Linked-color imaging endoscopyExperimental treatment 1 intervention
Group B: Chromoendoscopy with indigo carmine solution sprayActive comparator 1 intervention

Trial outcomes

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.

Time frame
Periprocedural

Secondary outcomes

1

detected rate of different lesions

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

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

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