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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jandee Lee, Korean Association of Endocrine Surgeons
ClinicalTrials.gov Identifier:
NCT01648569
First received: July 18, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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.


Condition
Papillary Thyroid Microcarcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Proper Extent of Surgery for Papillary Microcarcinoma

Resource links provided by NLM:


Further study details as provided by Korean Association of Endocrine Surgeons:

Primary Outcome Measures:
  • Overall survival in patients with papillary thyroid microcarcinoma [ Time Frame: Overall survival (10-year) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Disease-free survival in patients with papillary thyroid microcarcinoma [ Time Frame: Disease-free survival (10-year) ] [ Designated as safety issue: Yes ]
    We analyzed disease-free survival in patients with PTMC. We also compared the disease-free 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.


Enrollment: 2014
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Study population 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). Patients were followed-up for a median 11.8 years (range, 5 to 26 years). All histopathologic diagnoses were reviewed and verified by endocrine pathologists using WHO criteria. The study protocol was approved by our Institutional Review Board. Details of patients' presentations, surgical and pathologic findings, and adjunctive treatments were obtained from the Yonsei University Thyroid Cancer Database.

Management strategy In patients diagnosed with PTMC after a complete radiologic and histologic examination, the extent of thyroidectomy and radioactive iodine (RI) therapy were based on prognostic factors. However, the protocol of our institution as to how PTMC should be appropriately managed has been changed according to update of clinical reports and validated treatment guidelines. Therefore, the lack of a standardized approach during the study period allowed us to assess the impact of various therapeutic modalities, especially extent of thyroidectomy, in patients with PTMC.

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with follow-up loss
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648569

Locations
Korea, Republic of
Yonsei University College of Medicidine
Seoul, Korea, Republic of
Sponsors and Collaborators
Korean Association of Endocrine Surgeons
Investigators
Study Chair: Woong Youn Chung Yonsei University
  More Information

No publications provided

Responsible Party: Jandee Lee, MD PhD, Korean Association of Endocrine Surgeons
ClinicalTrials.gov Identifier: NCT01648569     History of Changes
Other Study ID Numbers: KoreanAES003
Study First Received: July 18, 2012
Last Updated: July 23, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Papillary
Thyroid Diseases
Thyroid Neoplasms
Carcinoma
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 27, 2014