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

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.

Study Overview

• Status: Completed
• Conditions: Papillary Thyroid Cancer; Well Differentiated Thyroid Carcinoma
• Intervention / Treatment: Procedure: UNILATERAL THYROIDECTOMY

• Study Type: Observational
• Enrollment (Actual): 301

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 61 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The medical charts of all patients who underwent thyroid surgery between January 2006 and December 2018 in TASMC were retrieved. Most of them were females. The mean age of the entire cohort was 49.59 ± 15.17 years (median 50 years, interquartile range 38-61].

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UPSCALED	Procedure: UNILATERAL THYROIDECTOMY; Other Names: TOTAL THYROIDECTOMY
NOT UPSCALED	Procedure: UNILATERAL THYROIDECTOMY; Other Names: TOTAL THYROIDECTOMY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-specific recurrence	WDTC recurrence	2006-2018

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Low risk, Risk stratification, Partial thyroidectomy, Hemithyroidectomy, Completion Thyroidectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Disease Attributes; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Recurrence; Thyroid Diseases; Thyroid Neoplasms; Thyroid Cancer, Papillary
• Other Study ID Numbers: TASMC-20-NC-TLV-704-16-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No