Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
3 year after surgery
Sun-Whe Kim, MD., PhD.
Seoul National University Hospital
Korea: Food and Drug Administration