Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
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|ClinicalTrials.gov Identifier: NCT01974284|
Recruitment Status : Terminated (Lack of patient enrollment)
First Posted : November 1, 2013
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Papillary Thyroid Cancer||Drug: percutaneous ethanol ablation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||March 2, 2017|
|Actual Study Completion Date :||June 29, 2017|
Experimental: 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.
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.
- Disease-free [ Time Frame: 5 years ]Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
- Overall Survival [ Time Frame: 5 years ]Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
- Quality of Life [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974284
|United States, Connecticut|
|Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Glenda Callender, MD||Yale University- Department of Surgery|