Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pancreatic Cancer Pancreatic Surgery |
Procedure: Pancreaticoduodenectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital. |
- Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Postoperative hospital stay. Measuring the length of hospital stay. [ Time Frame: At day of discharge ] [ Designated as safety issue: No ]
| Enrollment: | 610 |
| Study Start Date: | August 2001 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: High volume surgeons
high volume surgeons performed at least 18 PD/year.
|
Procedure: Pancreaticoduodenectomy |
|
Active Comparator: Low volume surgeons
low volume surgeons performed less than 18 PD/year.
|
Procedure: Pancreaticoduodenectomy |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009
Exclusion Criteria:
- Other type of surgery
Contacts and Locations More Information
Publications:
| Responsible Party: | Marco Braga, MD, San Raffaele University |
| ClinicalTrials.gov Identifier: | NCT01059097 History of Changes |
| Other Study ID Numbers: | PANCREAS2010 |
| Study First Received: | January 25, 2010 |
| Last Updated: | January 28, 2010 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013