Papillary Thyroid Cancer
Conditions
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.
Interventions
DRUGpercutaneous 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.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free | 5 years | Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients. |
| Overall Survival | 5 years | Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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. |
| Patient Satisfaction | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Percutaneous Ethanol Ablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Disease-free
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
Time frame: 5 years
Population: Patients were not followed as the study was terminated.
Primary
Overall Survival
Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
Time frame: 5 years
Population: Patients were not followed as the study was terminated.
Secondary
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.
Time frame: 5 years
Population: Patients were not followed as the study was terminated.
Secondary
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.
Time frame: 5 years
Population: Patients were not followed as the study was terminated.