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| Name | Class |
|---|---|
| Universitat de les Illes Balears | OTHER |
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The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.
The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG | Experimental | Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green | Drug | Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calcemia | Serum calcium level at 24 hours postoperatively | Day 1 after surgery |
| Subjective parathyroid fluorescence | Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured on a subjective analogue scale (0: no fluorescence, 1: hypofluorescence or heterogeneous fluorescence, 2: homogeneous hyperfluorescence). | Intraoperatively |
| Objective parathyroid fluorescence | Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Patient's age | Baseline |
| Sex | Patient's gender | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime BonnĂn Pascual, MD | Contact | 871205959 | jaime.bonnin@ssib.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Son Espases | Recruiting | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26864909 | Background | Vidal Fortuny J, Belfontali V, Sadowski SM, Karenovics W, Guigard S, Triponez F. Parathyroid gland angiography with indocyanine green fluorescence to predict parathyroid function after thyroid surgery. Br J Surg. 2016 Apr;103(5):537-43. doi: 10.1002/bjs.10101. Epub 2016 Feb 11. | |
| 29405252 | Background | Vidal Fortuny J, Sadowski SM, Belfontali V, Guigard S, Poncet A, Ris F, Karenovics W, Triponez F. Randomized clinical trial of intraoperative parathyroid gland angiography with indocyanine green fluorescence predicting parathyroid function after thyroid surgery. Br J Surg. 2018 Mar;105(4):350-357. doi: 10.1002/bjs.10783. Epub 2018 Feb 6. |
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| ID | Term |
|---|---|
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Single group: patients undergoing total thyroidectomy with intraoperative infusion of intravenous indocyanine green A prospective unicentric and open clinical trial in which the fluorescence intensity of the parathyroid glands after indocyanine administration will be compared between two groups of patients: those with post-thyroidectomy hypocalcemia and patients who do not present it.
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|
| Body mass index |
Patient's BMI |
| Baseline |
| Surgery date | Day when surgery takes place | Baseline |
| Preoperative diagnosis | Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis) | Baseline |
| Vitamin D | Preoperative vitamin D level | Preoperative blood test |
| PTH preop | Preoperative PTH level | Immediately before surgery |
| PTH 10 min | PTH levels 10 minutes post-thyroidectomy | 10 minutes post-thyroidectomy |
| Surgery | Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection | Inmediately after surgery |
| Time | Duration of surgery | Inmediately after surgery |
| Parathyroid glands | Number of parathyroid glands located during surgery, | During surgery |
| Parathyroid gland location | Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left). | During surgery |
| Pathologic result | Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis) | during the first month after surgery |
| Thyroid weight | Thyroid weight | during the first month after surgery |
| PG in piece | Presence of parathyroid glands in the surgical piece and number | during the first month after surgery |
| Stay | Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours | During the first month after surgery |
| Drain | Presence and number of surgical drainages | Inmediately after surgery |
| PTH day 1 | PTH levels in the postoperative follow-up, | Day 1 after surgery |
| Complications | Emergence of postoperative complications. | During the first month after surgery |
| 27839936 | Background | Lang BH, Wong CK, Hung HT, Wong KP, Mak KL, Au KB. Indocyanine green fluorescence angiography for quantitative evaluation of in situ parathyroid gland perfusion and function after total thyroidectomy. Surgery. 2017 Jan;161(1):87-95. doi: 10.1016/j.surg.2016.03.037. Epub 2016 Nov 10. |
| 27041628 | Background | Zaidi N, Bucak E, Yazici P, Soundararajan S, Okoh A, Yigitbas H, Dural C, Berber E. The feasibility of indocyanine green fluorescence imaging for identifying and assessing the perfusion of parathyroid glands during total thyroidectomy. J Surg Oncol. 2016 Jun;113(7):775-8. doi: 10.1002/jso.24237. Epub 2016 Apr 4. |
| 30665612 | Background | Galvez-Pastor S, Torregrosa NM, Rios A, Febrero B, Gonzalez-Costea R, Garcia-Lopez MA, Balsalobre MD, Pastor-Perez P, Moreno P, Vazquez-Rojas JL, Rodriguez JM. Prediction of hypocalcemia after total thyroidectomy using indocyanine green angiography of parathyroid glands: A simple quantitative scoring system. Am J Surg. 2019 Nov;218(5):993-999. doi: 10.1016/j.amjsurg.2018.12.074. Epub 2019 Jan 4. |
| 30659346 | Background | Rudin AV, McKenzie TJ, Thompson GB, Farley DR, Lyden ML. Evaluation of Parathyroid Glands with Indocyanine Green Fluorescence Angiography After Thyroidectomy. World J Surg. 2019 Jun;43(6):1538-1543. doi: 10.1007/s00268-019-04909-z. |
| 30327136 | Result | Bonnin-Pascual J, Alvarez-Segurado C, Jimenez-Segovia M, Bianchi A, Bonnin-Pascual F, Molina-Romero FX, Gonzalez-Argente FX. Contributions of fluorescence to endocrine surgery. Cir Esp (Engl Ed). 2018 Nov;96(9):529-536. doi: 10.1016/j.ciresp.2018.09.005. Epub 2018 Oct 14. English, Spanish. |