Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma

Not Applicable

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Age 18 years and older
Diagnosis: single, cytology-proven papillary thyroid carcinoma measuring 1 cm or less in diameter (microcarcinoma, T1a), without visible extrathyroidal extension, and with negative central and lateral neck lymph nodes by ultrasound

Exclusion Criteria

Patient refusal to participate
History of prior thyroid or parathyroid surgery
Previous recurrent laryngeal nerve injury
Inability to make decisions or comply with follow up
Co-existing indication for thyroidectomy
Aggressive cytological or molecular features
Multifocal papillary thyroid carcinoma
Pregnant or breast-feeding
Anatomically unfavorable location of the tumor (proximity to recurrent laryngeal nerve or trachea)
Documented or suspected distant metastasis
History of radiation to neck or face
Family history of thyroid cancer

Arm && Interventions

Group	Intervention	Description
percutaneous ethanol ablation	percutaneous ethanol ablation	The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.

Primary Outcome Measures

Name	Time	Method
Disease-free	5 years	Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
Overall Survival	5 years	Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	5 years	The Short-Form-36 (SF-36) health survey is a patient-reported survery that evaluates the patient's health status. It consists of 8 scaled scores which are the weighted sums of the questions in each section. The 8 sections that are tested are vitality, physical functioning, bodily pain, general role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale; the higher the score, the less disability (i.e. the score of 0 is equivalent to maximal disability, and the score of 100 is equivalent of no disability). The SF-36 is a set of easily-administered quality-of-life measures and is a validated tool to evaluate patient quality of life.
Patient Satisfaction	5 years	Patient satisfaction will be assessed by evaluating the following: pain with the "Brief Pain Inventory" (BPI), voice with the "Voice Handicap Index" (VHI) and cosmesis with the "Patient and Observer Scar Assessment Scale" (POSAS). The BPI is a simple, well-accepted instrument for the objective assessment of pain. The VHI is an established tool used to assess voice after an intervention. POSAS is a validated tool for the evaluation of surgical scars.

Locations (1): Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven
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New Haven, Connecticut, United States