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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04115527
• Other study ID #: HBP-RCT-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Procedure:
• Extended Lymphadenectomy
Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes
• Standard Lymphadenectomy
Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 year overall survival rate	1 year overall survival rate	1 year post-operation
Primary	3 years overall survival rate	3 years overall survival rate	3 years post-operation
Primary	5 years overall survival rate	5 years overall survival rate	5 years post-operation
Secondary	Postoperative Complications	pancreatic fistula, bile leakage, haemorrhage, DGE, etc	Within 90 days or before discharge
Secondary	1, 3 & 5 years disease free survival rate	1, 3 & 5 years disease free survival rate	1, 3 & 5 years post-operation