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

Xinrui Zhu，MD

Status: Not yet enrolling

Conditions: Laparoscopic Pancreaticoduodenectomy

Treatments: Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05808894

2023-167-1

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

extended transection group

Experimental group

Description:

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

Treatment:

Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy

conventional transection group

No Intervention group

Description:

the patients in conventional transection group obtain conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy.