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OpenTrials
Completed

NCT Number: NCT01278381

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.

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Key information

Conditions

Pancreatic Neoplasm Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Raffaele Hospital

Milan, 20132, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing pancreaticoduodenectomy in our Institution

Exclusion criteria

  • Metastatic disease
  • Patient not suitable for surgery

Treatment and study plan

Pancreaticoduodenectomy

Procedure

Resection of pancreatic lesion

Primary outcomes

  1. Major Complication rate

    Time frame: Postoperative. Until 30 days after discharge

    Clavien-Dindo grade III to V complications considered as major

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Jan 17, 2011
Registry last updated
Jan 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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