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Spadispan: Prospective Snapshot Audit of Distal Pancreatectomy in Spain

Sponsor
Hospital General Universitario de Alicante (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04900012
Collaborator
(none)
500
Enrollment
16
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Distal pancreatectomy

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
SPAnish DIStal PANcreatectomy Snapshot Study
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Distal pancreatectomy

All cases operated on performing distal pancreatectomy in involved Units

Procedure: Distal pancreatectomy
We are going to collect all cases
Other Names:
  • corporocaudal pancreatectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Morbidity at 90 days [90 days]

      Morbidity measured with CCI and Clavien at 90 days

    2. Laparoscopic approach [1 year]

      Laparoscopic or laparotomy approach

    Secondary Outcome Measures

    1. Pancreatic fistula [90 days]

      Percentage of pancreatic fistula

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospital General Universitario de Alicante

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Candido Fernando Alcazar-Lopez, MD PHD Senior consultant HPB surgeon, Hospital General Universitario de Alicante
    ClinicalTrials.gov Identifier:
    NCT04900012
    Other Study ID Numbers:
    • 2021/078
    First Posted:
    May 25, 2021
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Fistula
    Pancreatic Diseases
    Fistula

    Study Results

    No Results Posted as of May 25, 2021