NCT06424431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
487

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

4.1 years

First QC Date

April 3, 2024

Last Update Submit

May 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative pancreatic fistula

    Postoperative pancreatic fistula

    perioperatively

Study Arms (2)

Stapler

OTHER

Simple closure with a closure device for closure of the pancreatic remnant in distal pancreatectomy.

Procedure: simple closure with a closure device

Stapler combined with electrocautery

EXPERIMENTAL

Closure with a closure device combined with electrocoagulation for closure of the pancreatic remnant in distal pancreatectomy.

Procedure: stapler combined with electrocautery

Interventions

Closure with a closure device combined with electrocoagulation for pancreatic stump closure in distal pancreatectomy

Stapler combined with electrocautery

Simple closure with a closure device for pancreatic stump closure in distal pancreatectomy

Stapler

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

Electrocoagulation

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2024

First Posted

May 22, 2024

Study Start

January 1, 2019

Primary Completion

January 31, 2023

Study Completion

April 1, 2024

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations