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Spots Global Cancer Trial Database for Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma

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Trial Identification

Brief Title: Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma

Official Title: Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma

Study ID: NCT01974284

Study Description

Brief Summary: We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven, New Haven, Connecticut, United States

Contact Details

Name: Glenda Callender, MD

Affiliation: Yale University- Department of Surgery

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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