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

NCT ID: NCT04115527

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

Detailed 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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard Lymphadenectomy

Intervention Type: PROCEDURE

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

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).

Group Type: EXPERIMENTAL

Extended Lymphadenectomy

Intervention Type: PROCEDURE

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

Interventions

Extended Lymphadenectomy

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

Intervention Type: PROCEDURE

Standard Lymphadenectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weishen WANG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiancheng WANG, Dr

Role: STUDY_DIRECTOR

Shanghai Ruijin Pancreatic Disease Center

Locations

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

HBP-RCT-003

Identifier Type: -

Identifier Source: org_study_id