NCT03967756UnknownNot Applicable
Impact of Automatic Polyp Detection System on Adenoma Detection Rate-a Multicenter,Prospective, Randomized Controlled Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Changhai Hospital
- Enrollment
- 1,118
- Locations
- 1
- Primary Endpoint
- adenoma detection rate(ADR)
Study Overview
Brief Summary
In recent years, with the continuous development of artificial intelligence, automatic polyp detection systems have shown its potential in increasing the colorectal lesions. Yet, whether this system can increase polyp and adenoma detection rates in the real clinical setting is still need to be proved. The primary objective of this study is to examine whether a combination of colonoscopy and a deep learning-based automatic polyp detection system is a feasible way to increase adenoma detection rate compared to standard colonoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged between 40-85 years old who have indications for screening, surveillance and diagnostic.
- •Patients who have signed inform consent form.
Exclusion Criteria
- •Patients who have undergone colonic resection
- •Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- •Patients with severe chronic cardiopulmonary and renal disease.
- •Patients who are unwilling or unable to consent.
- •Patients who are not suitable for colonoscopy
- •Patients who received urgent or therapeutic colonoscopy
- •Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
- •Patients who are taking aspirin, clopidogrel or other anticoagulants
- •Patients with withdrawal time < 6 min
Outcomes
Primary Outcomes
adenoma detection rate(ADR)
Time Frame: 30 minutes
the number of patients with at least one adenoma divided by the total number of patients.
Secondary Outcomes
- adenoma per colonoscopy(30 minutes)
- polyp per colonoscopy(30 minutes)
- polyp detection rate(PDR)(30 minutes)
Investigators
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital
Study Sites (1)
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