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

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Procedure: Standard Lymphadenectomy; Procedure: Extended Lymphadenectomy

• Registration Number: NCT04115527
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard lymphadenectomy	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
Extended lymphadenectomy	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).

Primary Outcome Measures

Name	Time	Method
3 years overall survival rate	3 years post-operation	3 years overall survival rate
5 years overall survival rate	5 years post-operation	5 years overall survival rate
1 year overall survival rate	1 year post-operation	1 year overall survival rate

Secondary Outcome Measures

Name	Time	Method
Postoperative Complications	Within 90 days or before discharge	pancreatic fistula, bile leakage, haemorrhage, DGE, etc
1, 3 & 5 years disease free survival rate	1, 3 & 5 years post-operation	1, 3 \& 5 years disease free survival rate

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China