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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03081351

Enrollment

480

Registered

2017-03-16

Start date

2016-06-01

Completion date

2019-12-31

Last updated

2017-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticoduodenectomy

Keywords

Extended retroperitoneal lymphadenectomy, Nerve plexus clearance, Survival benefit

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.

Interventions

PROCEDUREextended 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.

PROCEDUREstandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactWenhui Lou, MD

lou.wenhui@zs-hospital.sh.cn+8664041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026