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

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Procedure: Standard Lymphadenectomy; Procedure: Extended Lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04115527

HBP-RCT-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Standard lymphadenectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Standard Lymphadenectomy

Extended lymphadenectomy

Experimental group

Description:

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).

Treatment:

Procedure: Extended Lymphadenectomy