Surgery--ComplicationsSpadispanNCT04900012
Prospective Snapshot Audit of Distal Pancreatectomy in Spain
An observational study of Surgery--Complications and Pancreas Disease, run by Hospital General Universitario de Alicante.
Trial summary
Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgery--Complications, Pancreas Disease, Pancreatic Fistula
- What is being tested?
- Distal pancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All scheduled distal pancreatectomies performed in on year in each Unit.
Who may be able to join
- -All distal pancreatectomies performed in involved Units
Who cannot join
- No sign of informed consent for entering in the study
- Emergency procedures
About this study
Official title: SPAnish DIStal PANcreatectomy Snapshot Study
Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.
Read the detailed description
Snapshot observational study including most of the Spanish pancreatic units that perform distal pancreatectomy. One year consecutive cases.
Main objectives.
- percentage of laparoscopic approach in Spain
- Morbidity at 90 days measured by CCI and Clavien Dindo
- Percentage of pancreatic fistula
- Impact of new device to decrease pancreatic fistula
- Conditions
- Surgery--Complications, Pancreas Disease, Pancreatic Fistula
- Being tested
- Distal pancreatectomy
- Medical subject headings
- Pancreatic Diseases, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal pancreatectomyProcedure or surgery
Also called corporocaudal pancreatectomy
We are going to collect all cases
| Study group | Role | What they receive |
|---|---|---|
| Distal pancreatectomy | All cases operated on performing distal pancreatectomy in involved Units Receives: Procedure: Distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity at 90 days
Morbidity measured with CCI and Clavien at 90 days
Measured: 90 days
Laparoscopic approach
Laparoscopic or laparotomy approach
Measured: 1 year
Secondary outcomes (1)
Pancreatic fistula
Percentage of pancreatic fistula
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 posted25 May 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candido Fernando Alcazar-Lopez, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900012
- Sponsor's protocol ID
- 2021/078
- Acronym
- Spadispan
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: CRD is done. It should be sent to local investigators and fulfilled in a Castor formulary.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPAnish DIStal PANcreatectomy Snapshot Study
- ClinicalTrials.gov ID
- NCT04900012
- Acronym / sponsor ID
- Spadispan / 2021/078
- Conditions
- Surgery--Complications, Pancreas Disease, Pancreatic Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital General Universitario de AlicanteUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 25 May 2021 (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.
Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.
Detailed description
Snapshot observational study including most of the Spanish pancreatic units that perform distal pancreatectomy. One year consecutive cases.
Main objectives.
- percentage of laparoscopic approach in Spain
- Morbidity at 90 days measured by CCI and Clavien Dindo
- Percentage of pancreatic fistula
- Impact of new device to decrease pancreatic fistula
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal pancreatectomy | – | Procedure: Distal pancreatectomyAll cases operated on performing distal pancreatectomy in involved Units |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All scheduled distal pancreatectomies performed in on year in each Unit.
Key inclusion criteria (1 listed)
- -All distal pancreatectomies performed in involved Units
Key exclusion criteria (2 listed)
- No sign of informed consent for entering in the study
- Emergency procedures
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 |
|---|---|---|
| Distal pancreatectomyAlso: corporocaudal pancreatectomyWe are going to collect all cases | Procedure or surgery | Distal pancreatectomy |
Primary outcome
Morbidity at 90 days
Time frame: 90 days
Morbidity measured with CCI and Clavien at 90 days
Laparoscopic approach
Time frame: 1 year
Laparoscopic or laparotomy approach
1 secondary outcome
Pancreatic fistula
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: No. CRD is done. It should be sent to local investigators and fulfilled in a Castor formulary.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications and Pancreas Disease, run by Hospital General Universitario de Alicante.
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 1 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: status not confirmed, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity at 90 days (time frame: 90 days). The study lists 2 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 25 May 2021.