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Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

NCT ID: NCT01059097

Last Updated: 2010-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer Pancreatic Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High volume surgeons

high volume surgeons performed at least 18 PD/year.

Group Type ACTIVE_COMPARATOR

Pancreaticoduodenectomy

Intervention Type PROCEDURE

Low volume surgeons

low volume surgeons performed less than 18 PD/year.

Group Type ACTIVE_COMPARATOR

Pancreaticoduodenectomy

Intervention Type PROCEDURE

Interventions

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Pancreaticoduodenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion Criteria

* Other type of surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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San Raffaele University

Principal Investigators

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Marco Braga, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele University

Locations

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San Raffaele Scientific Institute

Milan, MI, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 18844251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17933001 (View on PubMed)

Other Identifiers

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PANCREAS2010

Identifier Type: -

Identifier Source: org_study_id