Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy
- Conditions
- Pancreatic Neoplasm
- Interventions
- Procedure: Pancreaticoduodenectomy
- Registration Number
- NCT01278381
- Lead Sponsor
- Università Vita-Salute San Raffaele
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
- Patients undergoing pancreaticoduodenectomy in our Institution
- Metastatic disease
- Patient not suitable for surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pancreaticoduodenectomy (PD) Pancreaticoduodenectomy Patients undergoing PD from 2002 to 2010
- Primary Outcome Measures
Name Time Method Major Complication rate Postoperative. Until 30 days after discharge Clavien-Dindo grade III to V complications considered as major
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
San Raffaele Hospital
🇮🇹Milan, Italy