Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059097

San Raffaele Scientific Institute
Milan, MI, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Principal Investigator: Marco Braga, MD San Raffaele University
  More Information

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 Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 26, 2016