Study Stopped
Lack of patient enrollment
Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
1 other identifier
interventional
7
1 country
1
Brief Summary
We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2017
CompletedResults Posted
Study results publicly available
November 25, 2019
CompletedNovember 25, 2019
November 1, 2019
3 years
October 25, 2013
November 1, 2019
November 1, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Disease-free
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
5 years
Overall Survival
Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
5 years
Secondary Outcomes (2)
Quality of Life
5 years
Patient Satisfaction
5 years
Study Arms (1)
percutaneous ethanol ablation
EXPERIMENTALThe experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06520, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Glenda Callendar
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Glenda Callender, MD
Yale University- Department of Surgery
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2013
First Posted
November 1, 2013
Study Start
March 1, 2014
Primary Completion
March 2, 2017
Study Completion
June 29, 2017
Last Updated
November 25, 2019
Results First Posted
November 25, 2019
Record last verified: 2019-11