Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT)

Study Overview
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Brief Summary
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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.

Official Title
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Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT): a Multicenter Randomized Controlled Trial

Conditions
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Laparoscopic Pancreaticoduodenectomy

Intervention / Treatment
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* Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas. 18 years old < age < 80 years old, no gender limit. Patient is expected survival beyond 3 months. No pregnancy or pregnancy plan within 3 months after surgery. Nutrition risk score <3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score. No contraindication to surgery for anesthetic evaluation. The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up. Exclusion Criteria: Patients with borderline resectable and unresectable malignancies. Patients undergoing neoadjuvant chemotherapy or radiotherapy. Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography. Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction. Operation transfers to open. Operation transfers to other procedure. The main pancreatic duct can not be found intraoperatively, the duct-to-mucosa pancreaticojejunostomy can not be operated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: extended transection group<br>the patients in extended transection group obtain extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy. | Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy<br>* Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein.<br>|
| No Intervention: conventional transection group<br>the patients in conventional transection group obtain conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of clinically relevant pancreatic fistula | the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading | 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| location of the pancreatic duct in the pancreatic transverse section | Before performing the pancreaticojejunostomy, place the pancreatic transverse section in the central position of the lens. Measure the anterior-posterior diameter of the pancreas and the distance of the pancreatic duct from the back of the pancreas. The location of the pancreatic duct in the pancreatic transverse section is equal to the ratio of the distance of the pancreatic duct from the back of the pancreas to the anterior-posterior diameter of the pancreas. | intraoperatively | 
| surgical performance of pancreaticojejunostomy | the duration of pancreaticojejunostomy | intraoperatively | 
| postoperative morbidity | postoperative morbidity (Clavien-Dindo score ≥3）within 3 months postoperatively | 3 months postoperatively | 
| postoperative mortality | mortality within 3 months postoperatively | 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic pancreaticoduodenectomy, pancreatic neck transection level