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Prognostic Factors in Periampullary Tumors and Cysts

Sponsor
Umeå University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05155878
Collaborator
(none)
500
Enrollment
1
Location
220
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    From november 2021 an onward, study participants will be prospectively enrolled within the observational study. Before that, study participants are retrospectively enrolled. The study has a broad perspective including studies on clinical outcomes and prognostics based on patient and tumor characteristics.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2035
    Anticipated Study Completion Date :
    Jan 1, 2040

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [10 years]

      Overall survival

    Secondary Outcome Measures

    1. Complications [10 years]

      Clavien-Dindo, Specific procedure related outcomes

    2. Radical resection [10 years]

      Rates of R0 vs R1/2 resections

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Recommended surgery for tumor or cyst in the pancreas or periampullary region

    • Information avalible in electronic journal files

    • Informed consent (or deceased for retrospective part of the study)

    Exclusion Criteria:
    • No informed consent (and still alive at study initiation)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Surgical Clinic at Umeå University Hospital Umeå Sweden 90185

    Sponsors and Collaborators

    • Umeå University

    Investigators

    • Principal Investigator: Oskar Franklin, MD/PhD, Umeå University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oskar Franklin, Principal Investigator, Umeå University
    ClinicalTrials.gov Identifier:
    NCT05155878
    Other Study ID Numbers:
    • UmU-parpanc
    First Posted:
    Dec 14, 2021
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cysts
    Pancreatic Neoplasms
    Bile Duct Neoplasms
    Pancreatic Fistula
    Pancreatic Diseases
    Fistula

    Study Results

    No Results Posted as of Jan 5, 2022