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The Incidence of Postoperative Re-stratification for Recurrence in Well-differentiated Thyroid Cancer - A Single Tertiary Israeli Center Experience

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04500925
Collaborator
(none)
301
Enrollment
168
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Background After diagnosing well-differentiated thyroid cancer (WDTC), careful assessment of the risk for disease-specific recurrence is essential for deciding between partial (low risk) and completion (high risk) thyroidectomies. Patients' preoperatively determined risk levels are re-stratified according to surgical and final histopathological findings. The American Thyroid Association 2015 guidelines suggest that patients with WDTC between 1-4 cm in size and without suspicious features may be suitable candidates for partial thyroidectomy. The incidence and clinical implications of high-risk features discovered postoperatively in patients with preoperatively determined low-risk WDTC have not been previously reported.

Methods All thyroidectomies performed between 2006-2018 in the Tel Aviv Sourasky Medical Center were included. Pre- and postoperative risk stratifications were performed, and the rate of completion thyroidectomy was determined. Patients with 1-4 cm WDTC without evidence of positive cervical lymph nodes, invasion to adjacent structures, or high-risk cytology were considered at low risk for disease-specific recurrence and therefore suitable for lobectomy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: UNILATERAL THYROIDECTOMY

Study Design

Study Type:
Observational
Actual Enrollment :
301 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Incidence of Postoperative Re-stratification for Recurrence in Well-differentiated Thyroid Cancer - A Single Tertiary Israeli Center Experience
Actual Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
UPSCALED

Procedure: UNILATERAL THYROIDECTOMY
Other Names:
  • TOTAL THYROIDECTOMY

    		•
    NOT UPSCALED

    Procedure: UNILATERAL THYROIDECTOMY
    Other Names:
  • TOTAL THYROIDECTOMY

    		•

    Outcome Measures

    Primary Outcome Measures

    1. disease-specific recurrence [2006-2018]

      WDTC recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    38 Years to 61 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • All patients who underwent thyroid surgery (partial and total) between 2006-2018 at Tel Aviv Sourasky Medical Center (TASMC) were included
    Exclusion Criteria:
    • Patients with evidence of cervical lymph node metastasis, other malignancies, adverse imaging features (i.e., extracapsular spread of thyroid malignancy, vocal cord paralysis or immobility in physical examination) were excluded from the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tel-Aviv Sourasky Medical Center
    ClinicalTrials.gov Identifier:
    NCT04500925
    Other Study ID Numbers:
    • TASMC-20-NC-TLV-704-16-CTIL
    First Posted:
    Aug 5, 2020
    Last Update Posted:
    Aug 5, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tel-Aviv Sourasky Medical Center
    Low risk, Risk stratification, Partial thyroidectomy, Hemithyroidectomy, Completion Thyroidectomy
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Thyroid Cancer, Papillary
    Thyroid Diseases
    Recurrence

    Study Results

    No Results Posted as of Aug 5, 2020