An interventional study of Pancreaticoduodenectomy in Pancreatic Cancer and Pancreatic Surgery, sponsored by Università Vita-Salute San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-01-29.
Sponsored by Università Vita-Salute San Raffaele · Not applicable, Interventional, and Treatment
The independent impact of surgeon volume on outcome of patients undergoing pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of pancreatic fistula rate was found in the high-volume surgeon group in comparison with low-volume surgeon group. However, no difference between groups was found in mortality, major complications, and hospital stay.
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.
Università Vita-Salute San Raffaele is the lead sponsor of 84 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
high volume surgeons performed at least 18 PD/year.
Procedure: Pancreaticoduodenectomy
low volume surgeons performed less than 18 PD/year.
Procedure: Pancreaticoduodenectomy
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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Università Vita-Salute San Raffaele