Impact of Automatic Polyp Detection System on Adenoma Detection Rate

Sponsor
Changhai Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03967756
Collaborator
The First Affiliated Hospital of Dalian Medical University (Other), Wenzhou Central Hospital (Other), Wuhan Union Hospital, China (Other)
1,118
1
2
28
39.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Automatic polyp detection system
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of Automatic Polyp Detection System on Adenoma Detection Rate-a Multicenter,Prospective, Randomized Controlled Trial
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jul 20, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: AI-assisted withdrawal group

A deep learning-based automatic polyp detection system was used to assist the endoscopist.

Device: Automatic polyp detection system
When colonoscopists withdraw the colonoscopies and inspect the colons, the video streaming of colonoscopies was real-time switched to the automatic polyp detection system, which made it feasible to detect lesions in real time. When any potential polyp is detected by the system, there will be a tracing box on an adjacent monitor to locate the lesion with a simultaneous sound alarm.

No Intervention: Routine withdrawal group

Routine withdrawal without any assist.

Outcome Measures

Primary Outcome Measures

  1. adenoma detection rate(ADR) [30 minutes]

    the number of patients with at least one adenoma divided by the total number of patients.

Secondary Outcome Measures

  1. polyp detection rate(PDR) [30 minutes]

    the number of patients with at least one polyp divided by the total number of patients.

  2. adenoma per colonoscopy [30 minutes]

    the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.

  3. polyp per colonoscopy [30 minutes]

    the number of polyps detected during colonoscopy withdraw divided by the number of colonoscopies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhai Hospital, Second Military Medical University Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital
  • The First Affiliated Hospital of Dalian Medical University
  • Wenzhou Central Hospital
  • Wuhan Union Hospital, China

Investigators

  • Principal Investigator: Zhaoshen Li, M.D, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT03967756
Other Study ID Numbers:
  • AI-2
First Posted:
May 30, 2019
Last Update Posted:
Apr 6, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2021