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Long-term Outcomes of Total Thyroidectomy Versus Less Than Total Thyroidectomy for Papillary Thyroid Microcarcinoma

NCT01648569 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2014

Last updated 2012-07-24

No results posted yet for this study

Summary

Although the vast majority of patients with Papillary Thyroid Microcarcinoma (PTMC) have excellent long-term outcomes, some patients experience tumor recurrence, either locally or, less frequently, as distant metastases, with some patients dying due to this disease. The natural course of PTMC has not always been universally accepted, thus creating controversy concerning the diagnosis and treatment of PTMC. Further, it is not yet possible to confidently identify PTMCs that would take aggressive courses if left untreated. Treatment recommendations range from observation alone to vigorous intervention featuring total thyroidectomy, prophylactic cervical lymph node dissection, and adjuvant RI ablation. Therefore, no consensus has yet been reached on the biological aggressiveness of PTMC or on which therapy is the most appropriate. Moreover, the impact of several clinicopathologic risk factors, including tumor size, is unclear, although patients with tumors ≤ 0.5cm in diameter may have a better prognosis than patients with tumors 0.5-1 cm in size.

Most studies evaluating the proper extent of surgery for PTMC have been retrospective in design. A prospective, long-term, randomized study in a large number of patients, however, may not be feasible owing to the need for an extensive follow-up duration, the costs associated with such a study, and, particularly, its ethical constraints. Consequently, it is not currently possible to determine the prognosis of patients with PTMC or the proper therapeutic approach in these patients. The investigators therefore compared long-term outcomes after total thyroidectomy (TT: total or near-total thyroidectomy) or less than total thyroidectomy (LT: lobectomy or subtotal thyroidectomy) in a large cohort of patients with PTMC, using propensity-score matching to adjust for the uncontrolled assignment of surgical extent in these patients. In addition, the investigators evaluated whether tumor size, ≤ 0.5 cm or \> 0.5 cm, had a significant impact in determining the extent of surgery in patients with PTMC.

Conditions

  • Papillary Thyroid Microcarcinoma

Sponsors & Collaborators

  • Korean Association of Endocrine Surgeons

    lead NETWORK

Principal Investigators

  • Woong Youn Chung · Yonsei University

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01648569 on ClinicalTrials.gov