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

Papillary Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500925
• Other study ID #: TASMC-20-NC-TLV-704-16-CTIL
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2018
• Gender: All
• Age group: 38 Years to 61 Years

Eligibility

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.

Related Conditions & MeSH terms

• Papillary Thyroid Cancer
• Recurrence
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms
• Well Differentiated Thyroid Carcinoma

Intervention

Procedure:
• UNILATERAL THYROIDECTOMY

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-specific recurrence	WDTC recurrence	2006-2018