Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
Conditions
Papillary Thyroid Cancer
Conditions: official terms
Carcinoma - Carcinoma, Papillary - Thyroid Diseases - Thyroid Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: percutaneous ethanol ablation
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
Status: Recruiting
Contact: Glenda Callender, MD - 203-737-2036 - glenda.callender@yale.edu
Start Date
March 2014
Completion Date
March 2018
Sponsors
Yale University
Source
Yale University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page