Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma

NCT ID: NCT01974284

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-06-29

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.

Conditions

Papillary Thyroid Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

percutaneous ethanol ablation

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

percutaneous; ethanol; ablation; papillary; thyroid; microcarcinoma; PTMC

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenda Callender, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University- Department of Surgery

Locations

Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HIC1312013168

Identifier Type: -

Identifier Source: org_study_id