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Lymph Node Metastases and Arterial Ligation in Rectal Cancer Surgery

Sponsor
Region Västmanland (Other)
Overall Status
Completed
CT.gov ID
NCT03314961
Collaborator
(none)
151
Enrollment
59
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Lymph node status is of major prognostic importance in non-metastatic rectal cancer. For oncological reasons, central arterial ligation of the inferior mesenteric artery (IMA) is suggested. However, there is no conclusive evidence presented for this procedure.

This study aimed at investigating the localisation of lymph node metastases and the role of central versus peripheral arterial ligation of in rectal cancer specimens.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective population-based study of specimens from patients that underwent surgical resection for rectal cancer in Västmanland County, Sweden. Specimens were divided in 3 sections (A-C) and the total amount of lymph nodes and the location of lymph node metastases were analysed.

    Multivariate analysis was used to explore the relationship between lymph node counts and age, gender, BMI, preoperative oncological treatment, type of surgery, tumour stage, vessel and specimen length.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    151 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Localisation of Mesenteric Lymph Node Metastases and Role of Level of Arterial Ligation in Rectal Cancer Surgery
    Actual Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Lymph node metastases in rectal cancer [2012-2016]

      Analyses of number and location of lymph node metastases in rectal cancer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients that were curatively operated for rectal cancer in Västmanlands county 2012-2016.
    Exclusion Criteria:
    • Patients that were not operated or had another type of cancer.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Region Västmanland

    Investigators

    • Principal Investigator: Catarina Tiselius, MD, PhD, Region Västmanland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Catarina Tiselius, MD, PhD, Region Västmanland
    ClinicalTrials.gov Identifier:
    NCT03314961
    Other Study ID Numbers:
    • Dnr2013/099
    First Posted:
    Oct 19, 2017
    Last Update Posted:
    Oct 19, 2017
    Last Verified:
    Oct 1, 2017
    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 Catarina Tiselius, MD, PhD, Region Västmanland
    rectal cancer
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Rectal Neoplasms
    Lymphatic Metastasis

    Study Results

    No Results Posted as of Oct 19, 2017