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Prospective Snapshot Audit of Distal Pancreatectomy in Spain

SPAnish DIStal PANcreatectomy Snapshot Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04900012
Acronym
Spadispan
Enrollment
500
Registered
2021-05-25
Start date
2021-07-01
Completion date
2022-10-31
Last updated
2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Disease, Pancreatic Fistula, Surgery--Complications

Brief 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. 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. 1. percentage of laparoscopic approach in Spain 2. Morbidity at 90 days measured by CCI and Clavien Dindo 3. Percentage of pancreatic fistula 4. Impact of new device to decrease pancreatic fistula

Interventions

PROCEDUREDistal pancreatectomy

We are going to collect all cases

Sponsors

Hospital General Universitario de Alicante
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

-All distal pancreatectomies performed in involved Units

Exclusion criteria

* No sign of informed consent for entering in the study * Emergency procedures

Design outcomes

Primary

MeasureTime frameDescription
Morbidity at 90 days90 daysMorbidity measured with CCI and Clavien at 90 days
Laparoscopic approach1 yearLaparoscopic or laparotomy approach

Secondary

MeasureTime frameDescription
Pancreatic fistula90 daysPercentage of pancreatic fistula

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026