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NCT06424431 Clinical Trial

Methods of Pancreatic Stump Closure for Distal Pancreatectomy

Pancreatectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06424431
Other study ID # CHEC2024-110
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date April 1, 2024

Study information
Verified date May 2024
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 487
Est. completion date April 1, 2024
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• stapler combined with electrocautery
Closure with a closure device combined with electrocoagulation for pancreatic stump closure in distal pancreatectomy
• simple closure with a closure device
Simple closure with a closure device for pancreatic stump closure in distal pancreatectomy

Locations
Country Name City State
China Changhai Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pancreatic fistula Postoperative pancreatic fistula perioperatively
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