Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy

November 8, 2023 updated by: Xinrui Zhu，MD
In this study, we analyze the common bleeding characteristics in laparoscopic pancreaticoduodenectomy by reviewing and annotating bleeding information from previous surgical videos as well as surgical operation OSATS technique scores. From there, we reflect on the correlation between surgical operating technique and intraoperative bleeding, as well as on the correlation between intraoperative bleeding and short-term postoperative outcomes.

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 periampullary benign and malignant diseases.

Description

Inclusion Criteria:

  • the surgical video is complete including the resection and reconstruction phases

Exclusion Criteria:

  • the surgical video is not complete
  • the cases 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 group
Cases who had underwent laparoscopic pancreaticoduodenectomy
Procedure: laparoscopic pancreaticoduodenectomy
laparoscopic pancreaticoduodenectomy was performed for periampullary benign and malignant diseases. Besides, the surgical video was recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative bleeding characteristics
Time Frame: intraoperatively
Bleeding characteristics include cause of bleeding, site of bleeding, size of bleeding, method of hemostasis, duration of hemostasis, and outcome of hemostasis. These would be obtained by reviewing and labeling laparoscopic pancreaticoduodenectomy surgical videos.
intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSATS scores
Time Frame: intraoperatively
Scoring laparoscopic pancreaticoduodenectomy operations using the OSATS Surgical Operative Technique Rating Scale
intraoperatively
textbook outcome
Time Frame: 3 months postoperatively
The textbook outcome was defined as the absence of all six individual outcomes: clinically relevant postoperative pancreatic fistula, post-pancreatectomy hemorrhage, bile leak, severe complications (Clavien-Dindo≥3), readmission, and mortality within 30 days postoperatively
3 months postoperatively

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)

October 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

February 25, 2024

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Estimated)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-1663-1

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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