Application and Optimization of the International Study Group of Pancreatic Surgery (ISGPS) Definition and Grading Criteria for Postoperative Complications of Pancreatic Surgery in Laparoscopic Pancreatic Surgery

December 10, 2022 updated by: Xinrui Zhu，MD, West China Hospital
In recent years, with the continuous development of minimally invasive techniques, laparoscopic pancreatic surgery has also been widely used. Although the postoperative mortality rate of laparoscopic pancreatic surgery has been decreasing as the technology continues to improve and mature, the complication rate reported varies widely among centers.The definition and grading criteria of ISGPS on postoperative complications of pancreatic surgery are mostly proposed based on open pancreatic surgery, and most of the data of the later related studies are also for open pancreatic surgery, while the applicability of the definition and grading criteria in laparoscopic pancreatic surgery is still lacking in systematic The study The main purpose of this study is to investigate the applicability of the ISGPS definition and grading criteria for pancreatic fistula, postoperative bleeding and delayed gastric emptying in laparoscopic pancreatic surgery.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. All patients underwent laparoscopic pancreatic resections at the Department of Pancreatic Surgery of West China Hospital of Sichuan University and the Department of Minimal Invasive Surgery of Shangjin Nanfu Hospital between January 2014 and July 2022.
  2. All patients underwent laparoscopic pancreaticoduodenectomy (LPD), laparoscopic distal pancreatectomy (LDP), laparoscopic enucleation, laparoscopic middle pancreatectomy (LMP), laparoscopic duodenum-preserving resection of head of pancreas (LDPRHP), or laparoscopic Frey procedure.
  3. Patients whose demographic parameters, perioperative clinical variables, postoperative follow-up outcomes for 3 months and total hospital costs can be collected completely.

Description

Inclusion Criteria:

  1. All patients underwent laparoscopic pancreatic resections at the Department of Pancreatic Surgery of West China Hospital of Sichuan University and the Department of Minimal Invasive Surgery of Shangjin Nanfu Hospital between January 2014 and July 2022.
  2. All patients underwent laparoscopic pancreaticoduodenectomy (LPD), laparoscopic distal pancreatectomy (LDP), laparoscopic enucleation, laparoscopic middle pancreatectomy (LMP), laparoscopic duodenum-preserving resection of head of pancreas (LDPRHP), or laparoscopic Frey procedure.
  3. Patients whose demographic parameters, perioperative clinical variables, postoperative follow-up outcomes for 3 months and total hospital costs can be collected completely.

Exclusion Criteria:

  1. Patients converted to laparotomy
  2. Patients underwent total pancreatectomy
  3. Patients underwent pancreatic pseudocyst drainage management
  4. Patients underwent pancreas biopsy

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Group with postoperative complications
Postoperative complications such as pancreatic fistula, postoperative bleeding and delayed gastric emptying
Group without postoperative complications
No postoperative complications such as pancreatic fistula, postoperative bleeding and delayed gastric emptying

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospitalization
Time Frame: Entire perioperative period
Including the patient's perioperative hospital stay, postoperative time to discharge, and length of stay in the ICU
Entire perioperative period
Medical expenses
Time Frame: Entire perioperative period
Including the entire hospitalization period, medicine, surgery, etc.
Entire perioperative period

Collaborators and Investigators

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

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2014

Primary Completion (Actual)

July 30, 2021

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

December 10, 2022

First Submitted That Met QC Criteria

December 10, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 10, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 126059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

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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