Papillary Thyroid Cancer Clinical Trial
Official title:
Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.
We hypothesize that percutaneous ethanol ablation (PEA) for primary papillary thyroid
microcarcinoma (PTMC) has equivalent oncologic outcomes to current treatment options
including observation, thyroid lobectomy and total thyroidectomy. In addition, we hypothesize
that it will yield superior long-term quality of life, including measures of pain, voice, and
cosmesis than standard surgical therapy (total thyroidectomy). If our hypotheses are correct,
the findings of this study have the potential to fundamentally change clinical management of
this group of patients.
This study was changed from its initial design: a 2 arm study comparing PEA to surgery
(Amended April 30, 2015). The change in design was made based on several discussions within
Yale Endocrine Surgery, with patients diagnosed with PTMC, and knowledge of other
institutions performing PEA for PTMC as standard of care.
The study team had been contacted by numerous potential subjects interested in PEA who were
unwilling to be randomized to surgery. Because patients interested in PEA appeared to be
firmly against the idea of thyroidectomy, we believed that we would be unable to enroll
sufficient patients to this study as the protocol originally stood.
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