HPB: Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit

• Sponsor: Fundacion Miguel Servet (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04556019
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Disease; Liver Diseases; Surgical Procedure, Unspecified; Bile Duct Diseases	Procedure: Hepatobiliopancreatic surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Results of the Surgical Treatment of Patients From Hepatobiliopancreatic Surgical Unit at the Complejo Hospitalario de Navarra
• Actual Study Start Date: Jan 3, 2019
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2029

Outcome Measures

Primary Outcome Measures

1. 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

2. Survival rate of patients operated by the HPB Surgical Unit [5-years post-surgery]

   These patients are operated due to tumoral cause

3. Disease-free 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

1. Assessment of standardization of pre and post-surgical care [90 days]

2. Evaluation of the result of the multimodal treatment [90 days]

3. Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause [5 years]

4. Assessment of the results from minimally invasive techniques in HPB surgery [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain	31008

Sponsors and Collaborators

• Fundacion Miguel Servet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundacion Miguel Servet
• ClinicalTrials.gov Identifier: NCT04556019
• Other Study ID Numbers: CIRUGIA HPB-CHN
• First Posted: Sep 21, 2020
• Last Update Posted: Sep 21, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fundacion Miguel Servet: Hepatobiliopancreatic surgery
• Additional relevant MeSH terms: Liver Diseases; Bile Duct Diseases; Pancreatic Diseases

Study Results

No Results Posted as of Sep 21, 2020