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NCT02787187 Clinical Trial

Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

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: Completed

Administrative data
NCT number NCT02787187
Other study ID # HBP-RCT-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date October 2021

Study information
Verified date November 2021
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer

Recruitment information / eligibility
Status Completed
Enrollment 230
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Pancreaticoduodenectomy with Standard lymphadenectomy
Pancreaticoduodenectomy:child's digestive reconstruction standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b
• Pancreaticoduodenectomy with Extended lymphadenectomy
Pancreaticoduodenectomy:child's digestive reconstruction extended lymphadenectomy: No8p 12a 12p 14c 14d 16

Locations
Country Name City State
China Shanghai Ruijin Hospital Shanghai Shanghai

Sponsors (3)
Lead Sponsor Collaborator
Ruijin Hospital Shanghai Zhongshan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality 3yrs post-operation
Secondary all-cause mortality 1yr post-operation
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