Methods of Pancreatic Stump Closure for Distal Pancreatectomy

Not Applicable

Completed

• Conditions: Pancreatectomy
• Interventions: Procedure: stapler combined with electrocautery; Procedure: simple closure with a closure device

• Registration Number: NCT06424431
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2019-01-01
• Primary Completion: 2023-01-31
• Study Completion: 2024-04-01
• Study First Submitted: 2024-04-03
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 487

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapler combined with electrocautery	stapler combined with electrocautery	Closure with a closure device combined with electrocoagulation for closure of the pancreatic remnant in distal pancreatectomy.
Stapler	simple closure with a closure device	Simple closure with a closure device for closure of the pancreatic remnant in distal pancreatectomy.

Primary Outcome Measures

Name	Time	Method
Postoperative pancreatic fistula	perioperatively	Postoperative pancreatic fistula

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China