Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

January 28, 2010 updated by: Università Vita-Salute San Raffaele

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

610

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20132
        • San Raffaele Scientific Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion Criteria:

  • Other type of surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge
Time Frame: 30 days after discharge
30 days after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 days post-discharge
Postoperative hospital stay. Measuring the length of hospital stay.
Time Frame: At day of discharge
At day of discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Investigators

  • Principal Investigator: Marco Braga, MD, San Raffaele University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (ESTIMATE)

January 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2010

Last Update Submitted That Met QC Criteria

January 28, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • PANCREAS2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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