Establishment and Application of an Artificial Intelligence Algorithm for Automatic Identification of Intraoperative Bleeding During Laparoscopic Pancreaticoduodenectomy

December 14, 2023 updated by: Xinrui Zhu，MD
Surgeons will label surgical videos of laparoscopic pancreaticoduodenectomy with bleeding information from multicenter. The labeled surgical video will be used as training material to train the algorithmic model so as to build an artificial intelligence algorithm that can automatically identify intraoperative bleeding in this surgery. Then, we will test the performance capability of the algorithm.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients underwent laparoscopic pancreaticoduodenectomy for benign and malignant diseases. Besides, the surgical videos had been recorded.

Description

Inclusion Criteria:

1. surgical videos that recorded complete laparoscopic pancreaticoduodenectomy including resection and reconstruction phases.

Exclusion Criteria:

1.surgical videos that recorded laparoscopic pancreaticoduodenectomy combined with resection and reconstruction of mesentericoportal vein.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LPD cohort
surgical videos of laparoscopic pancreaticoduodenectomy with label to build and test the algorithms.
Other: laparoscopic pancreaticoduodenectomy
we recorded the surgical videos of laparoscopic pancreaticoduodenectomy, and labeled the information in the video to build and test the algorithms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
performance of artifical intelligence algorithm
Time Frame: through study completion, an average of 1 month
test the performance of the algorithm , including accuracy
through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinrui Zhu，MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Estimated)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-1663-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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