NCT04556019

Brief Summary

The main aims of this study are:

  1. 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. 2.\- to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2019Jan 2029

Study Start

First participant enrolled

January 3, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Expected
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

5 years

First QC Date

June 11, 2019

Last Update Submit

September 15, 2020

Conditions

Keywords

Hepatobiliopancreatic surgery

Outcome Measures

Primary Outcomes (3)

  • 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

  • Survival rate of patients operated by the HPB Surgical Unit

    These patients are operated due to tumoral cause

    5-years post-surgery

  • 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 Outcomes (4)

  • Assessment of standardization of pre and post-surgical care

    90 days

  • Evaluation of the result of the multimodal treatment

    90 days

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

    5 years

  • Assessment of the results from minimally invasive techniques in HPB surgery

    90 days

Interventions

Different surgical techniques tailored to each patient´s pathology

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All out-patients and in-patients at the HPB Surgical Unit

You may qualify if:

  • 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).

You may not qualify if:

  • Patients not eligible for surgery
  • Patients not interested in taking part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Pancreatic DiseasesLiver DiseasesBile Duct Diseases

Condition Hierarchy (Ancestors)

Digestive System DiseasesBiliary Tract Diseases

Study Officials

  • Francisco Javier Herrera Cabezón, MD

    Complejo Hospitalario de Navarra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Javier Herrera Cabezón, MD

CONTACT

Pablo Sánchez Acedo, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2019

First Posted

September 21, 2020

Study Start

January 3, 2019

Primary Completion

January 1, 2024

Study Completion (Estimated)

January 1, 2029

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations