Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy

Not Applicable

• Conditions: Pancreaticoduodenectomy
• Interventions: Procedure: standard lymphadenectomy; Procedure: extended lymphadenectomy and nerve clearance

• Registration Number: NCT03081351
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

This clinical trial is about the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.

Detailed Description

The purpose of this clinical trial is for assessing the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma. And we will focus on the R0 resection using LEEPP(Leeds Pathology Protocol) methods to check whether the tumor is eradicated or not.

Study Timeline

• Study Start: 2016-06-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-05
• Study First Submitted QC: 2017-03-10
• Last Update Submitted: 2017-03-10
• Study First Posted: 2017-03-16
• Last Update Posted: 2017-03-16
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• 18-70 years; Karnofsky performance>70; preoperative diagnosis as resectable pancreatic head cancer; patients' relative have signed consent form.

Exclusion Criteria

• also have severe cardiopulmonary disease, autoimmune disease, chronic renal failure disease; recurrent pancreatic tumor or unresectable tumor; benign pancreatic tumor; also have other malignant tumors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard lymphadenectomy	standard lymphadenectomy	The investigators will implement the pancreaticoduodenectomy using the standard lymphadenectomy. The lymph node include 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b of the abdominal lymph node.
extended lymphadenectomy and nerve clearance	extended lymphadenectomy and nerve clearance	The investigators will implement the pancreaticoduodenectomy using the principle of "Total Peripancreas Excision" to resect the lymph node and nerve plexus. The lymph node include standard 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b and extended 8p,9,12a,12p,14a-d,16a2,16b1 of the abdominal lymph node.

Primary Outcome Measures

Name	Time	Method
Overall survival	From date of randomization until the date of death from any cause, assessed up to 100 months	The overall survival of the patients from the time of surgery until the date of pass-away.

Secondary Outcome Measures

Name	Time	Method
Disease free survival	From date of randomization until the date of first documented progression( local recurrence or metastasis), assessed up to 100 months.	The time of the surgery until the date of the local recurrence or metastasis.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China