NCT06172062

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

November 8, 2023

Last Update Submit

December 14, 2023

Conditions

Laparoscopic Pancreaticoduodenectomy

Keywords

laparoscopic pancreaticoduodenectomysurgical videosartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • performance of artifical intelligence algorithm

    test the performance of the algorithm , including accuracy

    through study completion, an average of 1 month

Study Arms (1)

LPD cohort

surgical videos of laparoscopic pancreaticoduodenectomy with label to build and test the algorithms.

Other: laparoscopic pancreaticoduodenectomy

Interventions

laparoscopic pancreaticoduodenectomyOTHER

we recorded the surgical videos of laparoscopic pancreaticoduodenectomy, and labeled the information in the video to build and test the algorithms.

LPD cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

He Cai, MD.

CONTACT

+862862539242813021545@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

November 8, 2023

First Posted

December 15, 2023

Study Start

July 20, 2023

Primary Completion

December 30, 2023

Study Completion

March 30, 2024

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)