Artificial Intelligence-assisted Common Bile Duct Stent Selection in Endoscopic Retrograde Cholangiopancreatography

Sponsor
Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05321472
Collaborator
(none)
600
1
11.4
52.8

Study Details

Study Description

Brief Summary

Common bile duct stenosis is an important indication for endoscopic retrograde cholangiopancreatography(ERCP). Appropriate selection of bile duct stent size is not only conducive to successful stent implantation but also to improve the prognosis of patients. Currently, the selection of stent specifications is based on the operator's empirical estimation, which is not only not accurate but also increases the radiation exposure time, causing unnecessary harm to both the operator and the patient. Our objective is to develop an artificial intelligence algorithm to automatically select appropriate stent.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Endoscopic Retrograde Cholangiopancreatography (ERCP) is an operation with high risk. Common bile duct stone and stenosis are important indications. The quality control of ERCP is the key to improve its success rate and reduce complications, which has received great attention. In 2015, the American Society of Gastrointestinal Endoscopy/American College of Gastroenterology (ASGE/ACG) issued ERCP quality control indicators, among which biliary stent placement and radiographic fluoroscopy time are important intraoperative quality control indicators.

    The selection of appropriate biliary stent size is not only conducive to successful stent implantation but also to improve the prognosis of patients. Choose a stent of appropriate length. The proximal side of the stent should be 1cm above the obstruction segment, and the distal tail should be located just outside the nipple. The length of the stent can be determined by measuring the distance between the proximal end of the obstruction and the nipple under X-ray.

    Current stent size selection is based on the operator's empirical estimation :(1) estimate the distance by endoscope diameter or cone length or catheter marking; (2) By retracting the guidewire, calculate the distance of the guidewire retracting between two points to estimate the length of the stent.The long radiation exposure time results in unnecessary injuries to both the operator and the patient.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Artificial Intelligence-assisted Common Bile Duct Stent Selection in Endoscopic Retrograde Cholangiopancreatography
    Actual Study Start Date :
    Apr 20, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    group for training the algorithm

    This group of images is used for training the algorithm of the artificial intelligence

    group for testing the algorithm

    This group of images is used for testing the algorithm of the artificial intelligence

    Outcome Measures

    Primary Outcome Measures

    1. The accuracy of the calculated length of the stents by the artificial intelligence [6 months]

      The length of the stent was calculated "the length from the stenosis to the papilla+2cm".The length of the stent selected by experts is the gold standard

    Secondary Outcome Measures

    1. The accuracy of the segmentation of the artificial intelligence [4 months]

      The accuracy of the segmentation of the common bile duct, duodenoscopy and stenosis lesions by the artificial intelligence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients older than 18 years old who underwent ERCP
    Exclusion Criteria:
    • failed cholangiopancreatography caused by failed intubation, gastric retention, duodenal disease and so on

    • patients proved no stenosis in common bile duct

    • poor cholangiograms due to the lack of contrast agent or insufficient filling of contrast agent (cholangiograms without the completed CBD or thumbnails)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology,QiLu Hospital,Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Shandong University

    Investigators

    • Study Chair: Yanqing Li, MD, PhD, Qilu Hospital, Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yanqing Li, Vice President of Qilu Hospital, Shandong University
    ClinicalTrials.gov Identifier:
    NCT05321472
    Other Study ID Numbers:
    • 2021-SDU-QILU-090
    First Posted:
    Apr 11, 2022
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 6, 2022