Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma

We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.

Study Overview

• Status: Terminated
• Conditions: Papillary Thyroid Cancer
• Intervention / Treatment: Drug: percutaneous ethanol ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: ethanol; percutaneous; ablation; papillary; thyroid; microcarcinoma; PTMC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	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.	5 years
Patient Satisfaction	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.	5 years

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Glenda Callender, MD, Yale University- Department of Surgery

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): March 2, 2017
• Study Completion (ACTUAL): June 29, 2017

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (ESTIMATE): November 1, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Thyroid Neoplasms; Thyroid Diseases; Thyroid Cancer, Papillary; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: HIC1312013168