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NCT Number: NCT05789459

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

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.

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Key information

Conditions

Distal Pancreatectomy Postoperative Pancreatic Fistula

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stapler

Device

Stapler

Suture

Other

Suture

Primary outcomes

  1. Postoperative pancreatic fistula (POPF)

    Time frame: Within 3 months after pancreatic surgery

    The outcome was POPF per the International Study Group of Pancreatic Surgery definition

Secondary outcomes

  1. delayed gastric emptying (DGE)

    Time frame: Within 3 months after pancreatic surgery

    identified and graded according to the ISGPS criteria

  2. postpancreatectomy hemorrhage (PPH)

    Time frame: Within 3 months after pancreatic surgery

    identified and graded according to the ISGPS criteria

  3. Chyle leak

    Time frame: Within 3 months after pancreatic surgery

    identified and graded according to the ISGPS criteria

  4. Surgical complications

    Time frame: Within 3 months after pancreatic surgery

    classified according to the Clavien-Dindo system

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2023
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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