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.

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.

Study Overview

• Status: Unknown
• Conditions: Pancreaticoduodenectomy
• Intervention / Treatment: Procedure: extended lymphadenectomy and nerve clearance; Procedure: standard lymphadenectomy

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 Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenhui Lou, MD; Phone Number: 2909 +8664041990; Email: lou.wenhui@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Wenhui Lou, MD; Phone Number: 3450 021-64041990; Email: wenhuilou@aliyun.com
      • Contact: Wenchuan Wu, MD; Phone Number: 2909 021-64041990; Email: wu.wenchuan@zs-hospital.sh.cn
      • Principal Investigator: Wenhui Lou, MD
      • Principal Investigator: Wenchuan Wu, MD
      • Sub-Investigator: Yuan Fang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Changhai Hospital; Huashan Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Second Affiliated Hospital, Sun Yat-Sen University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Jiangsu Provincial People's Hospital

Publications and helpful links

General Publications

• Jang JY, Kang MJ, Heo JS, Choi SH, Choi DW, Park SJ, Han SS, Yoon DS, Yu HC, Kang KJ, Kim SG, Kim SW. A prospective randomized controlled study comparing outcomes of standard resection and extended resection, including dissection of the nerve plexus and various lymph nodes, in patients with pancreatic head cancer. Ann Surg. 2014 Apr;259(4):656-64. doi: 10.1097/SLA.0000000000000384.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: March 5, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Extended retroperitoneal lymphadenectomy, Nerve plexus clearance, Survival benefit
• Other Study ID Numbers: 20170305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No