Methods of Pancreatic Stump Closure for Distal Pancreatectomy

May 20, 2024 updated by: Changhai Hospital

Stapler Versus Stapler Combined With Electrocautery for Pancreatic Transection and Stump Closure for Distal Pancreatectomy

The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation. This study aims to determine which method is safer and more feasible, with the potential to reduce postoperative complications, improve outcomes, facilitate better patient recovery, and thereby provide better guidance for clinical practice.

Study Type

Interventional

Enrollment (Actual)

487

Phase

  • Not Applicable

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
    • Shanghai
      • Shanghai, Shanghai, China
        • Changhai Hospital

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

Description

Inclusion Criteria:

  • Patients who underwent distal pancreatectomy performed by Director Jin Gang's team at Changhai Hospital affiliated with Naval Medical University between January 2019 and January 2023.
  • Patients who underwent closure of the pancreatic remnant using either simple closure or closure combined with electrocoagulation during surgery.

Exclusion Criteria:

  • Patients undergoing surgeries by other primary clinical teams during the same period.
  • Patients undergoing closure of the pancreatic remnant using methods other than those mentioned.
  • Patients who violate the requirements of the study protocol.
  • Patients with incomplete data collection in the hospital's diagnostic and treatment system.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stapler
Simple closure with a closure device for closure of the pancreatic remnant in distal pancreatectomy.
Procedure: simple closure with a closure device
Simple closure with a closure device for pancreatic stump closure in distal pancreatectomy
Experimental: Stapler combined with electrocautery
Closure with a closure device combined with electrocoagulation for closure of the pancreatic remnant in distal pancreatectomy.
Procedure: stapler combined with electrocautery
Closure with a closure device combined with electrocoagulation for pancreatic stump closure in distal pancreatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pancreatic fistula
Time Frame: perioperatively
Postoperative pancreatic fistula
perioperatively

Collaborators and Investigators

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

Sponsor

Changhai Hospital

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, 2019

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CHEC2024-110

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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