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

Pancreaticoduodenectomy Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03081351
• Other study ID #: 20170305
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2017
• Last updated: March 10, 2017
• Start date: June 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2017
• Source: Shanghai Zhongshan Hospital
• Contact: Wenhui Lou, MD
• Phone: +8664041990
• Email: lou.wenhui[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Changhai Hospital, Huashan Hospital, Jiangsu Provincial People's 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

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.