Pancreas DiseaseHPBNCT04556019
Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit
An observational study of Pancreas Disease and Liver Diseases, run by Fundacion Miguel Servet at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Pancreas Disease, Liver Diseases, Surgical Procedure, Unspecified
- What is being tested?
- Hepatobiliopancreatic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jan 2019to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All out-patients and in-patients at the HPB Surgical Unit
Who may be able to join
- 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).
Who cannot join
- Patients not eligible for surgery
- Patients not interested in taking part in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Pablo Sánchez, MD, 0034 848422187, pablosanchez_84@hotmail.com
Ruth García Rey, MSc, 0034 848422163, ruth.garcia.rey@navarra.es
About this study
Official title: Results of the Surgical Treatment of Patients From Hepatobiliopancreatic Surgical Unit at the Complejo Hospitalario de Navarra
The main aims of this study are:
- - 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.
- - to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.
- Being tested
- Hepatobiliopancreatic surgery
- Keywords
- Hepatobiliopancreatic surgery
- Medical subject headings
- Pancreatic Diseases, Liver Diseases, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatobiliopancreatic surgeryProcedure or surgery
Different surgical techniques tailored to each patient´s pathology
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days post-surgery
Survival rate of patients operated by the HPB Surgical Unit
These patients are operated due to tumoral cause
Measured: 5-years post-surgery
Disease-free survival rate of patients operated by the HPB Surgical Unit
These patients are operated due to tumoral cause
Measured: 5-years post-surgery
Secondary outcomes (4)
Assessment of standardization of pre and post-surgical care
Measured: 90 days
Evaluation of the result of the multimodal treatment
Measured: 90 days
Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause
Measured: 5 years
Assessment of the results from minimally invasive techniques in HPB surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start3 Jan 2019
- Primary completionJan 2024 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Herrera Cabezón, MD, Principal investigator, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556019
- Sponsor's protocol ID
- CIRUGIA HPB-CHN
- Acronym
- HPB
- Status last verified
- Sep 2020
- First submitted
- 11 Jun 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of the Surgical Treatment of Patients From Hepatobiliopancreatic Surgical Unit at the Complejo Hospitalario de Navarra
- ClinicalTrials.gov ID
- NCT04556019
- Acronym / sponsor ID
- HPB / CIRUGIA HPB-CHN
- Keywords
- Hepatobiliopancreatic surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aims of this study are:
- - 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.
- - to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All out-patients and in-patients at the HPB Surgical Unit
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients not eligible for surgery
- Patients not interested in taking part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatobiliopancreatic surgeryDifferent surgical techniques tailored to each patient´s pathology | Procedure or surgery | – |
Primary outcome
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
Survival rate of patients operated by the HPB Surgical Unit
Time frame: 5-years post-surgery
These patients are operated due to tumoral cause
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco Javier Herrera Cabezón, MD principal investigator
Complejo Hospitalario de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Disease and Liver Diseases, run by Fundacion Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Javier Herrera Cabezón, MD (0034 848422187, javier.herrera.cabezon@cfnavarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit (time frame: 90 days post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.