Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01059097
First received: January 25, 2010
Last updated: January 28, 2010
Last verified: January 2010
  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.

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion Criteria:

  • Other type of surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059097

Locations
Italy
San Raffaele Scientific Institute
Milan, MI, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Principal Investigator: Marco Braga, MD San Raffaele University
  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 April 17, 2014