Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059097
• Other study ID #: PANCREAS2010
• Status: Completed
• Phase: N/A
• First received: January 25, 2010
• Last updated: January 28, 2010
• Start date: August 2001
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: January 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion Criteria:

• Other type of surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatic Surgery

Intervention

Procedure:
• Pancreaticoduodenectomy

Locations

Country	Name	City	State
Italy	San Raffaele Scientific Institute	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324. — View Citation

Balzano G, Zerbi A, Capretti G, Rocchetti S, Capitanio V, Di Carlo V. Effect of hospital volume on outcome of pancreaticoduodenectomy in Italy. Br J Surg. 2008 Mar;95(3):357-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge		30 days after discharge	No
Secondary	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	No
Secondary	Postoperative hospital stay. Measuring the length of hospital stay.		At day of discharge	No