Parathyroid Adenoma, Parathyroid Diseases, Primary Hyperparathyroidism, Thyroid Disease
Conditions
Keywords
minimally-invasive radio-guided parathyroidectomy, in-vivo, ex-vivo, multi-phase SPECT/CT, individualized treatment
Brief summary
The radio-guided technique offers both help with in-vivo identification and ex-vivo confirmation of parathyroid adenoma. In-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.
Detailed description
Despite the relatively accurate preoperative topographic information, minimally invasive parathyroid surgery can still be very challenging, especially in the case of small adenoma in ectopic localization. Radioguided technique offers both help with in-vivo identification and ex-vivo confirmation of adenoma. Excellent ex-vivo radio guidance results are referred. But, in-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.
Interventions
PROCEDUREConventional (dual-phase) SPECT/CT
Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)
PROCEDUREMulti-phase SPECT/CT
Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)
PROCEDUREConventional minimally-invasive radio-guided parathyroidectomy
Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration
PROCEDUREIndividualised minimally-invasive radio-guided parathyroidectomy
Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking is being used in the study
Intervention model description
The patients are randomized into two parallel study arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients * No history of thyroid or parathyroid surgery * Diagnosis of primary hyperparathyroidism * Indication for 99mTc-MIBI SPECT/CT examination
Exclusion criteria
* Minor patients * Negative SPECT/CT findings * Patients refusing surgery * Previous combined surgery on the thyroid gland * Patients in high risk of general anesthesia * Patients who do not undergo surgery in the recommended time span
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ex-vivo accuracy (%) | 3 months | Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure. |
| In-vivo accuracy (%) | 3 months | Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background. |
| Ex-vivo sensitivity (%) | 3 months | Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure. |
| Ex-vivo specificity (%) | 3 months | Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure. |
| Success of surgery (%) | 3 months | Surgery was considered successful if there were lowering of parathyroid hormone serum level and calcemia to normal and histological confirmation of parathyroid gland adenoma/ hyperplasia. |
| In-vivo sensitivity (%) | 3 months | Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background. |
| In-vivo specificity (%) | 3 months | Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological parathyroid gland volume (ml) | Duration of surgery | The pathological parathyroid gland volume in millilitres will be measured and recorded. |
| Pathological parathyroid gland localisation (ectopic x eutopic) | Duration of surgery | The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded. |
| Operating time (minutes) | Duration of surgery | The operating time will be measured and recorded. |
Countries
Czechia
Outcome results
None listed