Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit

Recruiting

• Conditions: Bile Duct Diseases; Pancreas Disease; Liver Diseases; Surgical Procedure, Unspecified

• Registration Number: NCT04556019
• Lead Sponsor: Fundacion Miguel Servet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2019-06-11
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-21
• Primary Completion: 2024-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival rate of patients operated by the HPB Surgical Unit	5-years post-surgery	These patients are operated due to tumoral cause
Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit	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	5-years post-surgery	These patients are operated due to tumoral cause

Secondary Outcome Measures

Name	Time	Method
Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause	5 years
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

Trial Locations

Locations (1)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain