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Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01278381
First received: January 14, 2011
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications. No score is currently available to help identify the patient's surgical risk. The purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after PD.


Condition Intervention
Pancreatic Neoplasm
 Procedure: Pancreaticoduodenectomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Major Complication rate [ Time Frame: Postoperative. Until 30 days after discharge ] [ Designated as safety issue: No ]
    Clavien-Dindo grade III to V complications considered as major


Enrollment: 700
Study Start Date: January 2002
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pancreaticoduodenectomy (PD)
Patients undergoing PD from 2002 to 2010
 Procedure: Pancreaticoduodenectomy
Resection of pancreatic lesion

Detailed Description:

The investigators prospectively collected in an electronic database preoperative, intraoperative and outcome data of 700 patients undergoing PD in our Institution from 2002 to 2010. The investigators used a multivariate logistic regression analysis to create a new score to predict severe complications defined as Clavien-Dindo classification III, IV and V. The score was developed using a random two-thirds of the population (469 patients), and was then validated and calibrated in the remaining third of the patients (231).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

700 patients undergoing pancreaticoduodenectomy in our Institution from 2002 to 2010

Criteria

Inclusion Criteria:

- Patients undergoing pancreaticoduodenectomy in our Institution

Exclusion Criteria:

  • Metastatic disease
  • Patient not suitable for surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278381

Locations
Italy
San Raffaele Hospital
Milan, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Principal Investigator: Marco Braga, MD Università Vita-Salute San Raffaele
  More Information

No publications provided

Responsible Party: Marco Braga, MD, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01278381     History of Changes
Other Study ID Numbers: PANCREATICODUODENECTOMY_SCORE
Study First Received: January 14, 2011
Last Updated: January 14, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
pancreas, pancreaticoduodenectomy, major complications

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

ClinicalTrials.gov processed this record on May 23, 2013