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| Name | Class |
|---|---|
| Umraniye Education and Research Hospital | OTHER_GOV |
| The Hashemite University | OTHER |
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The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy with central lymph node compartment dissection.
Real-time intraoperative identification and functional maintenance of structures are of major importance in endocrine surgery, with a critical role in clinical outcomes and patients' quality of life. Despite the advances in preoperative imaging techniques, there is still need for precise intraoperative visualizing [1]. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons [1-3]. Nowadays, attention is attracted to intraoperative imaging techniques using Near Infrared Fluorescence (NIRF) with endogenous or exogenous contrast agents. These imaging techniques are attractive in biomedicine due to its high penetration depth and low scattering in human tissue [2].
Autofluorescence is the ability of several natural substances or drugs to be fluorescent after the absorbance of light or radiation. It has been already proved that parathyroid glands emit their own light after near-infrared (NIR) around 820nm , providing high contrast to the surrounding tissues. This made near-infrared autofluorescence a potential useful tool in hands of experienced endocrine surgeons in order to distinguish parathyroid glands from other anatomic structures during thyroidectomies.
Approximately 7.6% of thyroid surgeries resulted in hypoparathyroidism, with 75% of these cases being transient and 25% being chronic. The mechanisms that underlie hypoPTH are related to disruption of parathyroid arterial supply or venous drainage, mechanical injury, thermal or electrical injury, and either intentional or inadvertent partial or complete removal.
The aim of the present study is to evaluate the value of intra-operative autofluorescence imaging concerning the unintentional excision rate of parathyroids during total thyroidectomy with central lymph node compartment dissection. Moreover, we are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autofluorescence | The surgeon will perform the preplanned thyroidectomy with central lymph node compartment dissection with FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: Surgery date Duration of surgery Operation performed Procedure related comments Number and location of the visualized glands Intra-operative autofluorescence score (either 0 (no visualization or 1 visualization) for each gland | ||
| Control | The surgeon will perform the preplanned thyroidectomy with central lymph node compartment dissection without autofluorescence device. The following intraoperative variables will be recorded for all patients: Surgery date Duration of surgery Operation performed Procedure related comments Number and location of the visualized glands |
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| Measure | Description | Time Frame |
|---|---|---|
| The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy with central lymph node dissection | The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy with central lymph node dissection (TTCC). We will measure the number of parathyroids accidentally excised during TTCC with and without autofluorescence. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Detecting the changes of practice in performing total thyroidectomywith central lymph node dissection when monitoring parathyroids with autofluorescence. | If autofluorescence is proved to be a useful tool in endocrine surgeons hands, the preservation of parathyroid glands during thyroidectomy with central lymph node dissection would be easier. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Our sample size of 180 patients has been calculated after power analysis regarding other similar studies with an a=0.05 and Power=0.95.
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| Name | Affiliation | Role |
|---|---|---|
| Theodossis Papavramidis, MD, PhD | AHEPA University Hospital of Thessaloniki, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki | Thessaloniki | 54621 | Greece |
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| Correlating autofluorescence with 24 hours post-operative PTH. | To identify any correlation between intra-operative parathyroid glands autofluorescence with postoperative hypoparathyroidism. We are going to evaluate the number of parathyroids evaluated and we are going to correlate it with PTH. | 6 months |
| Correlating autofluorescence with postoperative hypocalcemia | To identify any correlation between intra-operative parathyroid glands autofluorescence with postoperative hypoparathyroidism. We are going to evaluate the number of parathyroids evaluated and we are going to correlate it with Ca. | 7months |
| Identifying and analyzing problematic groups of patients | This study will sign out the disadvantages of FLUOBEAM XS or cases that its use should be avoided. | 7 months |
| Department of Surgery, Faculty of Medicine, Hashemite University | Zarqa | 13133 | Jordan |
| Umraniye Education and Research Hospital | Istanbul | 34764 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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