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
NCT number | NCT05789459 |
Other study ID # | DP-POPF |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | June 30, 2021 |
Verified date | March 2023 |
Source | Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
China,
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 |
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