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

Not Applicable

Not yet recruiting

• Conditions: Laparoscopic Pancreaticoduodenectomy
• Interventions: Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy

• Registration Number: NCT05808894
• Lead Sponsor: Xinrui Zhu，MD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-04-08
• Study First Posted: 2023-04-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-20
• Study Start: 2023-08
• Primary Completion: 2026-03
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas.
2. 18 years old < age < 80 years old, no gender limit.
3. Patient is expected survival beyond 3 months.
4. No pregnancy or pregnancy plan within 3 months after surgery.
5. Nutrition risk score <3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score.
6. No contraindication to surgery for anesthetic evaluation.
7. The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.

Exclusion Criteria

1. Patients with borderline resectable and unresectable malignancies.
2. Patients undergoing neoadjuvant chemotherapy or radiotherapy.
3. Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography.
4. Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction.
5. Operation transfers to open.
6. Operation transfers to other procedure.
7. The main pancreatic duct can not be found intraoperatively, the duct-to-mucosa pancreaticojejunostomy can not be operated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
extended transection group	extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy	the patients in extended transection group obtain extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy.

Primary Outcome Measures

Name	Time	Method
the incidence of clinically relevant pancreatic fistula	3 months postoperatively	the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading

Secondary Outcome Measures

Name	Time	Method
surgical performance of pancreaticojejunostomy	intraoperatively	the duration of pancreaticojejunostomy
postoperative mortality	3 months postoperatively	mortality within 3 months postoperatively
location of the pancreatic duct in the pancreatic transverse section	intraoperatively	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.
postoperative morbidity	3 months postoperatively	postoperative morbidity (Clavien-Dindo score ≥3）within 3 months postoperatively

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China