Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit
HPB
Results of the Surgical Treatment of Patients From Hepatobiliopancreatic Surgical Unit at the Complejo Hospitalario de Navarra
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2019
CompletedFirst Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
ExpectedSeptember 21, 2020
September 1, 2020
5 years
June 11, 2019
September 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit
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
These patients are operated due to tumoral cause
5-years post-surgery
Disease-free survival rate of patients operated by the HPB Surgical Unit
These patients are operated due to tumoral cause
5-years post-surgery
Secondary Outcomes (4)
Assessment of standardization of pre and post-surgical care
90 days
Evaluation of the result of the multimodal treatment
90 days
Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause
5 years
Assessment of the results from minimally invasive techniques in HPB surgery
90 days
Interventions
Different surgical techniques tailored to each patient´s pathology
Eligibility Criteria
All out-patients and in-patients at the HPB Surgical Unit
You may qualify if:
- 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).
You may not qualify if:
- Patients not eligible for surgery
- Patients not interested in taking part in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francisco Javier Herrera Cabezón, MD
Complejo Hospitalario de Navarra
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2019
First Posted
September 21, 2020
Study Start
January 3, 2019
Primary Completion
January 1, 2024
Study Completion (Estimated)
January 1, 2029
Last Updated
September 21, 2020
Record last verified: 2020-09