Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.

Conditions
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Pancreatic Cancer, Pancreatic Surgery

Intervention / Treatment
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* Procedure: Pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009 Exclusion Criteria: Other type of surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High volume surgeons<br>high volume surgeons performed at least 18 PD/year. | Procedure: Pancreaticoduodenectomy<br> <br> |
| Active Comparator: Low volume surgeons<br>low volume surgeons performed less than 18 PD/year. | Procedure: Pancreaticoduodenectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge |  | 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity rate measuring the following complications: pancreatic fistula, biliary fistula, delayed gastric emptying, infectious complications, bleeding, cardiovascular complications, respiratory complications. |  | 30 days post-discharge | 
| Postoperative hospital stay. Measuring the length of hospital stay. |  | At day of discharge |