Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy

Distal Pancreatectomy Clinical Trial

Official title:

Comparison of Outcomes With Stapler Versus Hand-Sewn Closure of the Pancreatic Stump Following Minimally Invasive Distal Pancreatectomy: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789459
• Other study ID #: DP-POPF
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental. Researchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP. Therefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Underwent elective minimally invasive pancreatic body and tail resection with or without splenectomy

Exclusion Criteria:

• Incomplete medical records
• History of previous pancreatic operations
• Emergent operation
• Conversion to open pancreatectomy
• Receipt of wedge resection or other procedures

Related Conditions & MeSH terms

• Distal Pancreatectomy
• Fistula
• Pancreatic Fistula
• Postoperative Pancreatic Fistula

Intervention

Device:
• Stapler
Stapler

Other:
• Suture
Suture

Locations

Country	Name	City	State
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pancreatic fistula (POPF)	The outcome was POPF per the International Study Group of Pancreatic Surgery definition	Within 3 months after pancreatic surgery
Secondary	delayed gastric emptying (DGE)	identified and graded according to the ISGPS criteria	Within 3 months after pancreatic surgery
Secondary	postpancreatectomy hemorrhage (PPH)	identified and graded according to the ISGPS criteria	Within 3 months after pancreatic surgery
Secondary	Chyle leak	identified and graded according to the ISGPS criteria	Within 3 months after pancreatic surgery
Secondary	Surgical complications	classified according to the Clavien-Dindo system	Within 3 months after pancreatic surgery