Spots Global Cancer Trial Database for Standardization of Surgery on the Pancreatic Cancer

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Trial Identification

Brief Title: Standardization of Surgery on the Pancreatic Cancer

Official Title: Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

Study ID: NCT00679913

Conditions

Pancreatic Cancer

Interventions

Standard pancreatoduodenectomy

Extended pancreatoduodenectomy

Study Description

Brief Summary: This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

Detailed Description: In Japan and in some western treatment centers, there has been a general belief that more extensive surgery may improve outcome for patients with localized, operable pancreatic adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year overall survival rates in patients treated with pancreaticoduodenectomy plus extended lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and the United States failed to confirm a survival benefit from extended lymphadenectomy. Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies had a few pitfalls. The need for Well-designed randomised controlled study is the starting point of our study. This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.