Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Pancreatic Surgery
• Interventions: Procedure: Pancreaticoduodenectomy

• Registration Number: NCT01059097
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief Summary

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

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 Timeline

• Study Start: 2001-08
• Primary Completion: 2009-08
• Status Verified: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-28
• Last Update Submitted: 2010-01-28
• Study First Posted: 2010-01-29
• Last Update Posted: 2010-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

• Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion Criteria

• Other type of surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low volume surgeons	Pancreaticoduodenectomy	low volume surgeons performed less than 18 PD/year.
High volume surgeons	Pancreaticoduodenectomy	high volume surgeons performed at least 18 PD/year.

Primary Outcome Measures

Name	Time	Method
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge	30 days after discharge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Raffaele Scientific Institute; 🇮🇹 Milan, MI, Italy