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Sponsored by: |
Seoul National University Hospital |
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Information provided by: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00679913 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Procedure: Standard pancreatoduodenectomy Procedure: Extended pancreatoduodenectomy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy |
Estimated Enrollment: | 216 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
standard pancreatoduodenectomy
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Procedure: Standard pancreatoduodenectomy
Standard pancreatoduodenectomy
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2: Active Comparator
extended pancreatoduodenectomy
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Procedure: Extended pancreatoduodenectomy
Extended pancreatoduodenectomy
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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.
Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sun-Whe Kim, MD., PhD. | 82-2-2072-2315 | sunkim@plaza.snu.ac.kr |
Contact: Jin-Young Jang, MD., PhD. | 82-2-2072-2194 | jangjy4@snu.ac.kr |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Sun-Whe Kim, MD., PhD. 82-2-2072-2315 sunkim@plaza.snu.ac.kr |
Principal Investigator: | Sun-Whe Kim, MD., PhD. | Seoul National University Hospital |
Responsible Party: | Seoul National University Hospital ( Seoul National University Hospital ) |
Study ID Numbers: | H-0509-513-157 |
Study First Received: | May 15, 2008 |
Last Updated: | May 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00679913 |
Health Authority: | Korea: Food and Drug Administration |
Pancreatic cancer Pancreaticoduodenectomy Extended lymphadenectomy |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |