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ICALYRA: Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas.

Sponsor
Fondazione Policlinico Universitario Campus Bio-Medico (Other)
Overall Status
Completed
CT.gov ID
NCT05959213
Collaborator
(none)
2,034
Enrollment
277.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

In our multicenter retrospective study, preoperative CA 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A retrospective analysis have been conducted on more than 2.000 patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma radiologically resectable at the preoperative staging. Preoperatory levels of CA 19.9 were measured in order to identify a relation with nodal involvement at the pathological staging.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2034 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas: a Further Plea for Biological Resectability Criteria.
    Actual Study Start Date :
    Jan 1, 2000
    Actual Primary Completion Date :
    Jun 30, 2022
    Actual Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Quantitative data - Preoperatory levels of CA 19.9 (U/ml) [20 years]

      Define relation of quantitative data (CA 19.9 (U/ml)) with nodal positivity at the final pathological report

    Eligibility Criteria

    Criteria

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

    • All patients undergone pancreatoduodenectomy

    • No preoperative radiological suspicion of lymph node metastases.

    Exclusion Criteria:
    • Age < 18

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Campus Bio-Medico

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tommaso Farolfi, Principal investigator, Fondazione Policlinico Universitario Campus Bio-Medico
    ClinicalTrials.gov Identifier:
    NCT05959213
    Other Study ID Numbers:
    • FPUCampusBioMedico
    First Posted:
    Jul 25, 2023
    Last Update Posted:
    Jul 25, 2023
    Last Verified:
    Jul 1, 2023
    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
    Keywords provided by Tommaso Farolfi, Principal investigator, Fondazione Policlinico Universitario Campus Bio-Medico
    Ca 19.9
    Pancreatic adenocarcinoma
    Pancreatoduodenectomy
    Additional relevant MeSH terms:
    Adenocarcinoma
    Pancreatic Neoplasms
    Lymphatic Metastasis

    Study Results

    No Results Posted as of Jul 25, 2023