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

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03081351
• Collaborator: Huashan Hospital (Other), Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other), Changhai Hospital (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other), Jiangsu Provincial People's Hospital (Other), Second Affiliated Hospital, Sun Yat-Sen University (Other)
• Enrollment: 480
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 43
• Patients Per Site Per Month: 11.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreaticoduodenectomy	Procedure: extended lymphadenectomy and nerve clearance; Procedure: standard lymphadenectomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Dec 31, 2018
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03081351
• Other Study ID Numbers: 20170305
• First Posted: Mar 16, 2017
• Last Update Posted: Mar 16, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai Zhongshan Hospital: Extended retroperitoneal lymphadenectomy, Nerve plexus clearance, Survival benefit

Study Results

No Results Posted as of Mar 16, 2017