Clinical trial NCT01974284: Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
Official title: Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Papillary Thyroid Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease-free
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Secondary outcomes:
measure: Quality of Life
timeFrame: 5 years
measure: Patient Satisfaction
timeFrame: 5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
Study officials:
affiliation: Yale University- Department of Surgery
name: Glenda Callender, MD
role: PRINCIPAL_INVESTIGATOR
References: