Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy
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| First Received Date ICMJE | January 14, 2011 | ||||
| Last Updated Date | January 14, 2011 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy | ||||
| Official Title ICMJE | A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY. | ||||
| Brief Summary | 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. |
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| 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). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 700 patients undergoing pancreaticoduodenectomy in our Institution from 2002 to 2010 |
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| Condition ICMJE | Pancreatic Neoplasm | ||||
| Intervention ICMJE | Procedure: Pancreaticoduodenectomy
Resection of pancreatic lesion |
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| Study Group/Cohort (s) | Pancreaticoduodenectomy (PD)
Patients undergoing PD from 2002 to 2010
Intervention: Procedure: Pancreaticoduodenectomy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 700 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Patients undergoing pancreaticoduodenectomy in our Institution Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01278381 | ||||
| Other Study ID Numbers ICMJE | PANCREATICODUODENECTOMY_SCORE | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Marco Braga, MD, Università Vita-Salute San Raffaele | ||||
| Study Sponsor ICMJE | Università Vita-Salute San Raffaele | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Università Vita-Salute San Raffaele | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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