Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy

March 16, 2023 updated by: TingBo Liang, Zhejiang University

Comparison of Outcomes With Stapler Versus Hand-Sewn Closure of the Pancreatic Stump Following Minimally Invasive Distal Pancreatectomy: A Retrospective Cohort Study

The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental.

Researchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP.

Therefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

384

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • the First Affiliated Hospital, School of Medicine, Zhejiang University

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent MDP in our institution between July 2018 and June 2021.

Description

Inclusion Criteria:

  • Underwent elective minimally invasive pancreatic body and tail resection with or without splenectomy

Exclusion Criteria:

  • Incomplete medical records
  • History of previous pancreatic operations
  • Emergent operation
  • Conversion to open pancreatectomy
  • Receipt of wedge resection or other procedures

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
Stapler group
closure with a stapler
Device: Stapler
Stapler
Hand-sewn group
closure with suture
Other: Suture
Suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pancreatic fistula (POPF)
Time Frame: Within 3 months after pancreatic surgery
The outcome was POPF per the International Study Group of Pancreatic Surgery definition
Within 3 months after pancreatic surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delayed gastric emptying (DGE)
Time Frame: Within 3 months after pancreatic surgery
identified and graded according to the ISGPS criteria
Within 3 months after pancreatic surgery
postpancreatectomy hemorrhage (PPH)
Time Frame: Within 3 months after pancreatic surgery
identified and graded according to the ISGPS criteria
Within 3 months after pancreatic surgery
Chyle leak
Time Frame: Within 3 months after pancreatic surgery
identified and graded according to the ISGPS criteria
Within 3 months after pancreatic surgery
Surgical complications
Time Frame: Within 3 months after pancreatic surgery
classified according to the Clavien-Dindo system
Within 3 months after pancreatic surgery

Collaborators and Investigators

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

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Tingbo Liang, Zhejiang University

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 1, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-POPF

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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