Should A Standard Lymphadenectomy Include The No. 16 Lymph Nodes For Patients With Pancreatic Head Adenocarcinoma.

Study Overview

Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.

The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.

Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.

Pancreatic Ductal Adenocarcinoma

PROCEDURE: Extended Lymphadenectomy
PROCEDURE: Standard Lymphadenectomy

HBP-RCT-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-10-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-10-16
First Submitted that Met QC Criteria 2019-10-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-10-17
First Posted (ACTUAL) 2019-10-04	Results First Posted N/A	Last Verified 2023-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Standard lymphadenectomy Standard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes harvested during the pancreaticoduodenectomy with CHILD's digestive reconstruction	PROCEDURE: Standard Lymphadenectomy Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes
EXPERIMENTAL: Extended lymphadenectomy In addition to the standard lymphadenectomy, para-aortic lymph nodes (No16) is included, in particular No 16b1 lymph nodes (Lymph nodes along the psterior side of the pancreas between the aorta and inferior vena cava).	PROCEDURE: Extended Lymphadenectomy Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Standard lymphadenectomy

Standard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes harvested during the pancreaticoduodenectomy with CHILD's digestive reconstruction

PROCEDURE: Standard Lymphadenectomy

Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes

EXPERIMENTAL: Extended lymphadenectomy

In addition to the standard lymphadenectomy, para-aortic lymph nodes (No16) is included, in particular No 16b1 lymph nodes (Lymph nodes along the psterior side of the pancreas between the aorta and inferior vena cava).

PROCEDURE: Extended Lymphadenectomy

Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes

Primary Outcome Measures	Measure Description	Time Frame
1 year overall survival rate	1 year overall survival rate	1 year post-operation
3 years overall survival rate	3 years overall survival rate	3 years post-operation
5 years overall survival rate	5 years overall survival rate	5 years post-operation

Secondary Outcome Measures	Measure Description	Time Frame
Postoperative Complications	pancreatic fistula, bile leakage, haemorrhage, DGE, etc	Within 90 days or before discharge
1, 3 & 5 years disease free survival rate	1, 3 & 5 years disease free survival rate	1, 3 & 5 years post-operation

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pathologic diagnosis of pancreatic ductal adenocarcinoma
Signed the informed consents

Pathologic diagnosis of other pancreatic cancers
Pre-operative anti-cancer treatment
Recurrence patients
Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
Pre operative exam: Total bilirubin more than 250µmol/L
AJCC stage IV
Operation non radical

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Jiancheng WANG, Dr, Shanghai Ruijin Pancreatic Disease Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record