Trial Outcomes & Findings for Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma (NCT NCT01974284)
NCT ID: NCT01974284
Last Updated: 2019-11-25
Results Overview
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
TERMINATED
NA
7 participants
5 years
2019-11-25
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
Baseline characteristics by cohort
| Measure |
Percutaneous Ethanol Ablation
n=7 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Patients were not followed as the study was terminated.
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 5 yearsPopulation: Patients were not followed as the study was terminated.
Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: Patients were not followed as the study was terminated.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: Patients were not followed as the study was terminated.
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.
Outcome measures
Outcome data not reported
Adverse Events
Percutaneous Ethanol Ablation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Glenda Callendar
Yale University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place