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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

January 14, 2011
January 14, 2011
January 2002
October 2010   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
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Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy
A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.

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.

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).

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

700 patients undergoing pancreaticoduodenectomy in our Institution from 2002 to 2010

Pancreatic Neoplasm
Procedure: Pancreaticoduodenectomy
Resection of pancreatic lesion
Pancreaticoduodenectomy (PD)
Patients undergoing PD from 2002 to 2010
Intervention: Procedure: Pancreaticoduodenectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Patients undergoing pancreaticoduodenectomy in our Institution

Exclusion Criteria:

  • Metastatic disease
  • Patient not suitable for surgery
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01278381
PANCREATICODUODENECTOMY_SCORE
No
Marco Braga, MD, Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
Not Provided
Principal Investigator: Marco Braga, MD Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP