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

Ruijin Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

Extended LymphadenectomyPROCEDURE

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

Standard LymphadenectomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologic diagnosis of pancreatic ductal adenocarcinoma * Signed the informed consents Exclusion Criteria: * 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

Locations (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

1 year overall survival rate

Time frame: 1 year post-operation

3 years overall survival rate

Time frame: 3 years post-operation

5 years overall survival rate

Time frame: 5 years post-operation

Secondary Outcomes

Postoperative Complications

pancreatic fistula, bile leakage, haemorrhage, DGE, etc

Time frame: Within 90 days or before discharge

1, 3 & 5 years disease free survival rate

1, 3 \& 5 years disease free survival rate

Time frame: 1, 3 & 5 years post-operation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.