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Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

U

Università Vita-Salute San Raffaele

Status

Completed

Conditions

Pancreatic Surgery
Pancreatic Cancer

Treatments

Procedure: Pancreaticoduodenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01059097
PANCREAS2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

610 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion criteria

  • Other type of surgery

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

610 participants in 2 patient groups

High volume surgeons
Active Comparator group
Description:
high volume surgeons performed at least 18 PD/year.
Treatment:
Procedure: Pancreaticoduodenectomy
Low volume surgeons
Active Comparator group
Description:
low volume surgeons performed less than 18 PD/year.
Treatment:
Procedure: Pancreaticoduodenectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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