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

NCT03081351 | Unknown

• 1 other identifier: 20170305
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreaticoduodenectomy

Keywords

Extended retroperitoneal lymphadenectomy, Nerve plexus clearance, Survival benefit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disease free survival

  From date of randomization until the date of first documented progression( local recurrence or metastasis), assessed up to 100 months.

Study Arms (2)

extended lymphadenectomy and nerve clearance

EXPERIMENTAL

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

standard lymphadenectomy

EXPERIMENTAL

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

Interventions

extended lymphadenectomy and nerve clearance PROCEDURE

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.

extended lymphadenectomy and nerve clearance

standard lymphadenectomy PROCEDURE

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.

standard lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years; Karnofsky performance\>70; preoperative diagnosis as resectable pancreatic head cancer; patients' relative have signed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related 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.

  PMID: 24368638 BACKGROUND

Central Study Contacts

Wenhui Lou, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 16, 2017
• Study Start: June 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)