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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2026-06-30

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.

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Detailed Description

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Conditions

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Laparoscopic Pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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extended transection group

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

Group Type EXPERIMENTAL

extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy

Intervention Type PROCEDURE

Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein.

conventional transection group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy

Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No