NCT01974284

Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Papillary Thyroid Cancer

Interventions

Type	Name	Description
DRUG	percutaneous ethanol ablation	The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia.

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-03-02
• Completion: 2017-06-29
• First posted: 2013-11-01
• Last updated: 2019-11-25
• Results posted: 2019-11-25

Locations

1 site across 1 country: United States