Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT)
NCT05808894 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154
Last updated 2023-07-20
Summary
The investigators conduct the clinical randomized controlled trial to evaluate the superiority of extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD). The participants in the study group obtain extended pancreatic neck transection during LPD, while participants in the control group conventional pancreatic neck transection. The purposes of this study include: 1.Primary objective: To compare the incidence of clinically relevant pancreatic fistula (grades B-C according International Study Group on Pancreatic Surgery) between the study group and the control group. 2.Secondary objective: To compare the incidence of postoperative morbidity (Clavien-Dindo score ≥3)between the two groups. To compare the location of pancreatic duct and the surgical performance of pancreaticojejunostomy between the two groups.
Conditions
- Laparoscopic Pancreaticoduodenectomy
Interventions
- PROCEDURE
-
extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy
Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein.
Sponsors & Collaborators
-
The Affiliated Hospital Of Guizhou Medical University
collaborator OTHER -
Shandong Provincial Hospital
collaborator OTHER_GOV -
Qilu Hospital of Shandong University
collaborator OTHER -
Xinrui Zhu,MD
lead OTHER
Principal Investigators
-
Bing Peng, Professor · West China Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-31
- Primary Completion
- 2026-03-31
- Completion
- 2026-06-30
Countries
- China
Study Locations
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