Prognostic Score To Predict Major Complications After Pancreaticoduodenectomy

Pancreatic Neoplasm Clinical Trial

Official title:

A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278381
• Other study ID #: PANCREATICODUODENECTOMY_SCORE
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: January 14, 2011
• Start date: January 2002
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients undergoing pancreaticoduodenectomy in our Institution

Exclusion Criteria:

• Metastatic disease

• Patient not suitable for surgery

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Procedure:
• Pancreaticoduodenectomy
Resection of pancreatic lesion

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Complication rate	Clavien-Dindo grade III to V complications considered as major	Postoperative. Until 30 days after discharge	No