Papillary Thyroid Microcarcinoma
Conditions
Brief summary
This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)
Detailed description
Image-guided thermal ablations have been successfully applied in the treatment of several type of tumors, and have been recently proposed as a potential alternative to surgery also in patients with thyroid diseases, and named Minimally Invasive Treatments of the Thyroid (MITT). These minimally invasive treatments, compared to surgical treatment have similar efficacy, fewer complications, better quality of life, and better cosmetic outcomes. These procedures allow precise delivery of the heat locally to the lesion, sparing the surrounding thyroid tissue, and thus minimizing the invasiveness of the treatment and the impact on thyroid function. This study aim to establish a prospective registry of the cases of patients treated with MITT for a Papillary Thyroid MicroCarcinoma (PTMC), in order to validate the safety of the procedure and to set the basis for collecting long term results in a large cohort of patients.
Interventions
PROCEDUREimage-guided thermal ablation
image-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma
Sponsors
European Institute of Oncology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18years * Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT. * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion. * Patients must be accessible for follow-up
Exclusion criteria
* Tumors \> 1 cm, other citological type, refusal of MITT, unsuitable for MITT, unmanageable coagulative disorders * Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with major complications occurring within one month after the date of intervention | 1 month | Complications will be reported according to modified Society of Interventional Radiology (SIR) classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with local recurrence at 10 years | 10 years | Evaluation of disease free survival (DFS): percentage of patient whith a local recurrence at 10 years of follow up |
| Percentage of patients with distant metastasis at 10 years | 10 years | Evaluation of disease free survival (DFS): percentage of patient whith distant metastasis at 10 years of follow up |
| Percentage of patients died at 10 years | 10 years | Evaluation of Overall Survival (OS): Percentage of patients died at 10 years |
Countries
Italy
Contacts
Primary ContactGiovanni Mauri
Outcome results
None listed