Clinical trialPhase 3Completed
Standardization of Surgery on the Pancreatic Cancer
Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- November 2005
- Expected end
- December 2013
- Enrollment
- 244 participants
- Sites
- 1
- Primary outcomes
- Survival
- Sponsor
- Other
- Results posted
- 2014-06-06
- Last update
- 6 June 2014
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Survival [2 year after surgery]. Number, participants. Standard Pancreatoduodenectomy (n=83): 37; Extended Pancreatoduodenectomy (n=86): 31.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Morbidity [within 2 years after surgery]. Number, participants. Standard Pancreatoduodenectomy (n=83): 27; Extended Pancreatoduodenectomy (n=86): 37.