Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit (HPB)

September 15, 2020 updated by: Fundacion Miguel Servet

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

The main aims of this study are:

  1. - 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.
  2. - to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Sub-Investigator:
          • Pablo Sánchez Acedo, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Javier Herrera Cabezón, MD
        • Sub-Investigator:
          • Cruz Zazpe Ripa, MD
        • Sub-Investigator:
          • Antonio Tarifa Castilla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All out-patients and in-patients at the HPB Surgical Unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days post-surgery
Survival rate of patients operated by the HPB Surgical Unit
Time Frame: 5-years post-surgery
These patients are operated due to tumoral cause
5-years post-surgery
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
5-years post-surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Miguel Servet

Investigators

  • Principal Investigator: Francisco Javier Herrera Cabezón, MD, Complejo Hospitalario de Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2019

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

January 1, 2029

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

September 15, 2020

First Posted (ACTUAL)

September 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRUGIA HPB-CHN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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