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Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy

A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01278381
Enrollment
700
Registered
2011-01-17
Start date
2002-01-31
Completion date
2010-10-31
Last updated
2011-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasm

Keywords

pancreas, pancreaticoduodenectomy, major complications

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).

Interventions

PROCEDUREPancreaticoduodenectomy

Resection of pancreatic lesion

Sponsors

Università Vita-Salute San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

\- Patients undergoing pancreaticoduodenectomy in our Institution

Exclusion criteria

* Metastatic disease * Patient not suitable for surgery

Design outcomes

Primary

MeasureTime frameDescription
Major Complication ratePostoperative. Until 30 days after dischargeClavien-Dindo grade III to V complications considered as major

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026