Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy

July 15, 2023 updated by: Xinrui Zhu，MD

Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy: a Retrospective Propensity Score-matched Comparison

The level of pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD) is not conclusive. Theoretically, the level of pancreatic transection can significantly affect the occurrence of postoperative pancreatic fistula (POPF) by influencing both the blood supply to the anastomosis and the location of the main pancreatic duct in the pancreatic transverse section. The investigators conduct a retropective propensity score-matched comparison to compare the impact of extended pancreatic transection and conventional pancreatic transection on POPF and the performance of the pancreaticojejunostomy during LPD.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

184

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 Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients who had underwent laparoscopic pancreaticoduodenectomy

Description

Inclusion Criteria:

  1. consecutive patients underwent elective laparoscopic pancreaticoduodenectomy within October 2019 to April 2023
  2. the perioperative and follow-up study data information can be collected completely
  3. The level of pancreatic neck dissection can be determined by postoperative abdominal CT
  4. patients without the history of neoadjuvant chemotherapy or radiotherapy

Exclusion Criteria:

  1. conversion to laparotomy due to various reasons during operation;
  2. combined with resection and reconstruction of the portal vein or the superior mesenteric vein
  3. combined with other organ resection
  4. the perioperative and follow-up study data information can not be collected completely, or the level of pancreatic neck dissection can not be determined by postoperative abdominal CT
  5. patients with the history of neoadjuvant chemotherapy or radiotherapy
  6. the main pancreatic duct did not be found during the operation, the duct-to-mucosa pancreaticojejunostomy could not be performed

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
extended pancreatic transection cohort
cases in which the pancreatic transection was performed at the pancreatic neck beyond the left side of the mesenterico-portal axis during laparoscopic pancreaticoduodenectomy, as judged by postoperative abdominal CT scan.
Procedure: extended pancreatic transection during laparoscopic pancreaticoduodenectomy
the pancreatic transection was performed at the pancreatic neck beyond the left side of the mesenterico-portal axis during laparoscopic pancreaticoduodenectomy
conventional pancreatic transection cohort
cases in which the pancreatic transection was performed at the pancreatic neck above the mesenterico-portal axis during laparoscopic pancreaticoduodenectomy, as judged by postoperative abdominal CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of clinically relevant pancreatic fistula
Time Frame: 3 months postoperatively
the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical performance of pancreaticojejunostomy
Time Frame: intraoperatively
the duration of pancreaticojejunostomy
intraoperatively
postoperative mortality
Time Frame: 3 months postoperatively
mortality within 3 months postoperatively
3 months postoperatively
postoperative morbidity
Time Frame: 3 months postoperatively
postoperative morbidity (Clavien-Dindo score ≥3) within 3 months postoperatively
3 months postoperatively

Collaborators and Investigators

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

Sponsor

Xinrui Zhu，MD

Investigators

  • Study Chair: Bing Peng, 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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-167-2

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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