Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional (dual-phase) SPECT/CT | Experimental | Adult patients with primary hyperparathyroidism undergoing conventional (dual-phase) SPECT/CT (after 10 and 150 minutes) and conventional minimally-invasive radio-guided parathyroidectomy in a time span 2-3 hours from radionuclide administration. |
|
| Multi-phase SPECT/CT | Experimental | Adult patients with primary hyperparathyroidism undergoing multi-phase SPECT/CT (after 10, 90, 150, 210 minutes) and individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional (dual-phase) SPECT/CT | Procedure | Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of surgery (%) | 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. | 3 months |
| In-vivo sensitivity (%) | 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. | 3 months |
| In-vivo specificity (%) | 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. | 3 months |
| In-vivo accuracy (%) | 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. | 3 months |
| Ex-vivo sensitivity (%) | 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. | 3 months |
| Ex-vivo specificity (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time (minutes) | The operating time will be measured and recorded. | Duration of surgery |
| Pathological parathyroid gland volume (ml) | The pathological parathyroid gland volume in millilitres will be measured and recorded. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| VladimÃr Dedek, MD,PhD | University Hospital Ostrava | Study Chair |
| Martin Formánek, MD,PhD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
Individual participant data will be made available to other researchers upon request.
Not provided
Not provided
Not provided
Not provided
Not provided
The patients are randomized into two parallel study arms.
Not provided
Not provided
No masking is being used in the study
Not provided
| Multi-phase SPECT/CT | Procedure | Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes) |
|
| Conventional minimally-invasive radio-guided parathyroidectomy | Procedure | Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration |
|
| Individualised minimally-invasive radio-guided parathyroidectomy | Procedure | Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation. |
|
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.
| 3 months |
| Ex-vivo accuracy (%) | 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. | 3 months |
| Duration of surgery |
| Pathological parathyroid gland localisation (ectopic x eutopic) | The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded. | Duration of surgery |
| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D013959 | Thyroid Diseases |
| D010279 | Parathyroid Diseases |
| D010282 | Parathyroid Neoplasms |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided