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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
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.

Condition or disease Intervention/treatment Phase
Papillary Thyroid Cancer Drug: percutaneous ethanol ablation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arms and Interventions
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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:
  • percutaneous
  • ethanol
  • ablation
  • papillary
  • thyroid
  • microcarcinoma
  • PTMC


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Overall Survival [ Time Frame: 5 years ]
    Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Connecticut
Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Glenda Callender, MD Yale University- Department of Surgery
  Study Documents (Full-Text)

Documents provided by Yale University:
Study Protocol and Statistical Analysis Plan  [PDF] April 13, 2016

More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01974284    
Other Study ID Numbers: HIC1312013168
First Posted: November 1, 2013    Key Record Dates
Results First Posted: November 25, 2019
Last Update Posted: November 25, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Adenocarcinoma, Papillary
 Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs