A Prospective Cohort Study on Ligation of Pancreatic Stump After Distal Pancreatectomy

February 23, 2025 updated by: Wuhan Union Hospital, China

A Prospective Cohort Study on Ligation of Pancreatic Stump With Quantified Force During Distal Pancreatectomy

The goal of this clinical trial is to learn if igation of pancreatic stump with quantified force works in decrease postoperative pancreatic fistula following distal pancreatectomy. The main outcome measures are:

Postoperative pancreatic fistula; Postoperative hospital stay.

Researchers will compare ligation to other pancreatic stump closure techniques to see if it decrease postoperative pancreatic fistula and postoperative hospital stay following distal pancreatectomy.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Introduction The closure of pancreatic stump after distal pancreatectomy remains controversial. Currently, the main methods of pancreatic stump closure include manual suturing and stapler closure. However, both methods carry a high risk of pancreatic fistula, which may be associated with the difficulty of balancing the provision of sufficient pancreatic duct burst pressure and ensuring blood supply to the stump. Through in vitro experiments, we demonstrated that applying quantified ligation forces to pancreatic stumps can provide a pancreatic duct burst pressure of approximately 50-70 mmHg. This burst pressure is higher than the upper limit of normal pancreatic duct pressure and lower than the normal mean arterial pressure, theoretically balancing the pancreatic duct burst pressure and stump blood supply. Therefore, we designed this prospective cohort study to verify the above hypothesis.

Methods and analysis This is a prospective cohort study at single centre in China. The major eligibility criterion is the presence of lesions planned for distal pancreatectomy. The texture of the pancreas was determined by the surgeon and the first assistant during the operation as soft, medium, or hard. After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force. Postoperative regular follow-up will be performed. The primary outcomes included pancreatic fistula and postoperative hospital stay, and the secondary outcomes included intra-abdominal infection, incision infection, and postoperative treatment costs. The primary outcomes and secondary outcomes of patients in this cohort will be statistically compared with historical data using appropriate tests.

Ethics and dissemination The study has been approved by the Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology(2024-0833-02). The results of the study will be published in an international peer-reviewed journal.

Study Type

Interventional

Enrollment (Estimated)

60

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
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Uion Hospital, Tongji Medical College, HUST

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 fully understand this study, voluntarily participate, and sign the Informed Consent Form (ICF);
  • Age between 18 and 75 years old;
  • Planned for distal pancreatectomy (including body and tail of the pancreas);
  • The intended pancreatic transection line is located on the left side of the portal vein.

Exclusion Criteria:

  • History of previous pancreatic surgery;
  • Additional surgical procedures required for the residual pancreas;
  • Proximal pancreatic duct obstruction, with planned anastomosis between the residual pancreas and the digestive tract;
  • Use of long-acting somatostatin analogues during the perioperative period;
  • Patients who are judged by the investigator to be unsuitable for participation in this study.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.
Other: ligation of pancreatic stump with a quantified force
After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.
Active Comparator: Control group
Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).
Other: Manual suturing or stapling closure.
Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic fistula
Time Frame: Up to half a year from enrollment
Postoperative pancreatic fistula adopts the definition proposed by the International Study Group of Pancreatic Surgery.
Up to half a year from enrollment
Postoperative hospital stay
Time Frame: Up to half a year from enrollment
Stay from operation to discharge.
Up to half a year from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-abdominal infection
Time Frame: Up to half a year from enrollment
Intra-abdominal infection is evaluated based on Common Terminology Criteria for Adverse Event (CTCAE) V.5.0.
Up to half a year from enrollment
Incision infection
Time Frame: Up to half a year from enrollment
Incision infection is evaluated based on Common Terminology Criteria for Adverse Event (CTCAE) V.5.0.
Up to half a year from enrollment
Postoperative treatment costs
Time Frame: Up to half a year from enrollment
Treatment costs of postoperative period.
Up to half a year from enrollment

Collaborators and Investigators

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

Sponsor

Wuhan Union Hospital, China

Investigators

  • Principal Investigator: Shanmiao Gou, MD, Ph.D, Union Hospital, HUST, Wuhan, China

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)

November 21, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 23, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS-PF

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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