Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
Primary Purpose
Papillary Thyroid Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
percutaneous ethanol ablation
Sponsored by
About this trial
This is an interventional treatment trial for Papillary Thyroid Cancer
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
Sites / Locations
- Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
percutaneous ethanol ablation
Arm Description
The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.
Outcomes
Primary Outcome Measures
Disease-free
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
Overall Survival
Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01974284
Brief Title
Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
Official Title
Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of patient enrollment
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
percutaneous ethanol ablation
Arm Type
Experimental
Arm Description
The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.
Intervention Type
Drug
Intervention Name(s)
percutaneous ethanol ablation
Other Intervention Name(s)
percutaneous, ethanol, ablation, papillary, thyroid, microcarcinoma, PTMC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free
Description
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
Time Frame
5 years
Title
Overall Survival
Description
Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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.
Time Frame
5 years
Title
Patient Satisfaction
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenda Callender, MD
Organizational Affiliation
Yale University- Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
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Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
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