Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059097
Recruitment Status : Completed
First Posted : January 29, 2010
Last Update Posted : January 29, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Surgery Procedure: Pancreaticoduodenectomy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 610 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.
Study Start Date : August 2001
Actual Primary Completion Date : August 2009
Actual Study Completion Date : January 2010

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U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge [ Time Frame: 30 days after discharge ]

Secondary Outcome Measures :
  1. 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 ]
  2. Postoperative hospital stay. Measuring the length of hospital stay. [ Time Frame: At day of discharge ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion Criteria:

  • Other type of surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Marco Braga, MD, San Raffaele University Identifier: NCT01059097     History of Changes
Other Study ID Numbers: PANCREAS2010
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases