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Clinical Trials/NCT04556019
NCT04556019
Recruiting
Not Applicable

Results of the Surgical Treatment of Patients From Hepatobiliopancreatic Surgical Unit at the Complejo Hospitalario de Navarra

Fundacion Miguel Servet1 site in 1 country1,000 target enrollmentJanuary 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreas Disease
Sponsor
Fundacion Miguel Servet
Enrollment
1000
Locations
1
Primary Endpoint
Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

The main aims of this study are:

    • to evaluate post-surgical morbidity and mortality outcomes, following the criteria and the definitions from Claven-Dindo and ISGPS international classifications, of the patients operated by the HPB Surgical Unit.
    • to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.
Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
January 2029
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundacion Miguel Servet
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All patients operated by the HPB Surgical Unit in the last 10 years (retrospective)
  • All patients being operated by the HPB Surgical Unit from January 2019 onwards who provide inform consent (prospective).

Exclusion Criteria

  • Patients not eligible for surgery
  • Patients not interested in taking part in the study

Outcomes

Primary Outcomes

Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit

Time Frame: 90 days post-surgery

Morbidity and mortality outcomes are evaluated following the criteria and definitions from Claven-Dindo and ISGPS international classifications

Survival rate of patients operated by the HPB Surgical Unit

Time Frame: 5-years post-surgery

These patients are operated due to tumoral cause

Disease-free survival rate of patients operated by the HPB Surgical Unit

Time Frame: 5-years post-surgery

These patients are operated due to tumoral cause

Secondary Outcomes

  • Evaluation of the result of the multimodal treatment(90 days)
  • Assessment of standardization of pre and post-surgical care(90 days)
  • Assessment of the results from minimally invasive techniques in HPB surgery(90 days)
  • Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause(5 years)

Study Sites (1)

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