Clinical Trials Directory

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UnknownNCT03081351

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

Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head in a Chinese Population:A Multicenter, Open-label, Randomized Controlled Clinical Trial.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
480 (estimated)
Sponsor
Shanghai Zhongshan Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREextended lymphadenectomy and nerve clearanceThe 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.
PROCEDUREstandard lymphadenectomyThe 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.

Timeline

Start date
2016-06-01
Primary completion
2018-12-31
Completion
2019-12-31
First posted
2017-03-16
Last updated
2017-03-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03081351. Inclusion in this directory is not an endorsement.