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

NCT01648569 | Completed DMC

• 1 other identifier: KoreanAES003
• Study Type: observational
• Target: 2,014
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall survival in patients with papillary thyroid microcarcinoma

  We analyzed overall survival in patients with PTMC. We also compared the overall survival between total thyroidectomy group versus less than total thyroidectomy group. Survival curves were constructed using the Kaplan-Meier method and compared using the log-rank test.

  Overall survival (10-year)

Secondary Outcomes (1)

• Disease-free survival in patients with papillary thyroid microcarcinoma

  Disease-free survival (10-year)

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We evaluated 2014 patients with PTMC who underwent TT (n=1015) or LT (n=999) between March 1986 and December 2006 and for whom complete follow-up data were available for at least 5 years (median 11.8 years; range 5-26 years).

You may qualify if:

• From March 1986 to December 2006, a total of 5042 patients with PTC (of all tumor sizes) underwent initial surgical therapy at our institution. Of these, 2441 patients (48.4%) had PTMCs ≤1 cm in diameter, with 1270 undergoing TT and 1171 undergoing LT. Complete follow-up data for major clinical events were available for 2014 patients (82.5%), including 1015 (79.9%) of the TT group and 999 (85.3%) of the LT group (p=0.083). All histopathologic diagnoses were reviewed and verified by endocrine pathologists using WHO criteria.

You may not qualify if:

• Patients with follow-up loss

Sponsors & Collaborators

• Korean Association of Endocrine Surgeons: lead

Study Sites (1)

Yonsei University College of Medicidine

Seoul, South Korea

Location

MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Study Officials

• Woong Youn Chung

  Yonsei University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 24, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

KR (1)