Clinical trial NCT01059097: Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy
Official title: Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Pancreatic Surgery
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion Criteria:

* Other type of surgery

Primary outcomes:
measure: Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Postoperative morbidity rate measuring the following complications: pancreatic fistula, biliary fistula, delayed gastric emptying, infectious complications, bleeding, cardiovascular complications, respiratory complications.
timeFrame: 30 days post-discharge
measure: Postoperative hospital stay. Measuring the length of hospital stay.
timeFrame: At day of discharge
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Scientific Institute
state: MI
Study officials:
affiliation: San Raffaele University
name: Marco Braga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1002/bjs.5982.