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Recruiting NCT04556019

Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit

— Observational Pancreas Disease Liver Diseases Surgical Procedure, Unspecified Bile Duct Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hepatobiliopancreatic surgery.
Who it may be relevant to
Registry conditions: Pancreas Disease, Liver Diseases, Surgical Procedure, Unspecified, Bile Duct Diseases. Basic parameters: 15 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit [Time frame: 90 days post-surgery]
  • Survival rate of patients operated by the HPB Surgical Unit [Time frame: 5-years post-surgery]
  • Disease-free survival rate of patients operated by the HPB Surgical Unit [Time frame: 5-years post-surgery]
Secondary outcome measures (4)
  • Assessment of standardization of pre and post-surgical care [Time frame: 90 days]
  • Evaluation of the result of the multimodal treatment [Time frame: 90 days]
  • Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause [Time frame: 5 years]
  • Assessment of the results from minimally invasive techniques in HPB surgery [Time frame: 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Complejo Hospitalario de Navarra — Pamplona

Identifiers

NCT: NCT04556019 · CIRUGIA HPB-CHN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗