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NCT Number: NCT04556019

Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit

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.

Recruiting

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Key information

Conditions

Pancreas Disease Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Liver Diseases Pancreatic Diseases Surgical Procedure, Unspecified

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location status: Recruiting

Location contact

Antonio Tarifa Castilla, MD

SUB_INVESTIGATOR

Cruz Zazpe Ripa, MD

SUB_INVESTIGATOR

Francisco Javier Herrera Cabezón, MD

PRINCIPAL_INVESTIGATOR

Pablo Sánchez Acedo, MD

SUB_INVESTIGATOR

Pablo Sánchez, MD

CONTACT

[email protected]

0034 848422187

Ruth García Rey, MSc

CONTACT

[email protected]

0034 848422163

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatobiliopancreatic surgery

Procedure

Different surgical techniques tailored to each patient´s pathology

Primary outcomes

  1. 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

  2. Survival rate of patients operated by the HPB Surgical Unit

    Time frame: 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

    Time frame: 5-years post-surgery

    These patients are operated due to tumoral cause

Secondary outcomes

  1. Assessment of standardization of pre and post-surgical care

    Time frame: 90 days

  2. Evaluation of the result of the multimodal treatment

    Time frame: 90 days

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

    Time frame: 5 years

  4. Assessment of the results from minimally invasive techniques in HPB surgery

    Time frame: 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco Javier Herrera Cabezón, MD

CONTACT

[email protected]

0034 848422187

Pablo Sánchez Acedo, MD

CONTACT

[email protected]

0034 848422187

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Registry information

Official study title

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

Acronym: HPB

Important dates

Study start
2019
Primary completion
2024
Study completion
2029
First posted
Sep 21, 2020
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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