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Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278381
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
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.
Information provided by:
Università Vita-Salute San Raffaele
  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.

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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Marco Braga, MD, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01278381     History of Changes
Other Study ID Numbers: PANCREATICODUODENECTOMY_SCORE
First Submitted: January 14, 2011
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
Last Verified: November 2010

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

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