Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy
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|ClinicalTrials.gov Identifier: NCT01059097|
Recruitment Status : Completed
First Posted : January 29, 2010
Last Update Posted : January 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Pancreatic Surgery||Procedure: Pancreaticoduodenectomy||Not Applicable|
Objectives: To define the independent impact of surgeon volume on outcome after pancreaticoduodenectomy (PD) in a single high-volume institution.
Summary Background Data: The impact of surgeon volume on PD outcome is still controversial. So far, data available are from retrospective multi-institutional reviews, considering in-hospital mortality as the only outcome variable.
Methods: Prospectively collected data on 610 patients who underwent PD from August 2001 to August 2009 were analyzed. Cut-off value to categorize high and low-volume surgeons (HVS and LVS, respectively) was 18 PD/year. Primary endpoint was operative mortality (death within 30-day post-discharge). Secondary endpoints were morbidity, pancreatic fistula (PF) and length of stay. Demographic, clinical, and surgical variables were recorded.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||610 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||January 2010|
Active Comparator: High volume surgeons
high volume surgeons performed at least 18 PD/year.
Active Comparator: Low volume surgeons
low volume surgeons performed less than 18 PD/year.
- Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge [ Time Frame: 30 days after discharge ]
- Postoperative morbidity rate measuring the following complications: pancreatic fistula, biliary fistula, delayed gastric emptying, infectious complications, bleeding, cardiovascular complications, respiratory complications. [ Time Frame: 30 days post-discharge ]
- Postoperative hospital stay. Measuring the length of hospital stay. [ Time Frame: At day of discharge ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059097
|San Raffaele Scientific Institute|
|Milan, MI, Italy, 20132|
|Principal Investigator:||Marco Braga, MD||San Raffaele University|