Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit

Liver Diseases Clinical Trial

— HPB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04556019
• Other study ID #: CIRUGIA HPB-CHN
• Status: Recruiting
• Start date: January 3, 2019
• Est. completion date: January 2029

Study information

• Verified date: September 2020
• Source: Fundacion Miguel Servet
• Contact: Francisco Javier Herrera Cabezón, MD
• Phone: 0034 848422187
• Email: javier.herrera.cabezon[@]cfnavarra.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2029
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Liver Diseases
• Pancreas Disease
• Pancreatic Diseases
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Hepatobiliopancreatic surgery
Different surgical techniques tailored to each patient´s pathology

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Survival rate of patients operated by the HPB Surgical Unit	These patients are operated due to tumoral cause	5-years post-surgery
Primary	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	Assessment of standardization of pre and post-surgical care		90 days
Secondary	Evaluation of the result of the multimodal treatment		90 days
Secondary	Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause		5 years
Secondary	Assessment of the results from minimally invasive techniques in HPB surgery		90 days