Does Indocyanine Imaging Scoring Predicts Postoperative Parathormone Levels at 24 Hours After Total Thyroidectomy

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the prognostic value of intra-operative indocyanine staining scoring concerning 24 hours post-operative PTH levels and the possible advantages that its' use can give in terms of clinical practice compared to conventionally operated patients.

Detailed Description
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Study objectives are: Detecting the changes of practice in performing total thyroidectomy with ICG. Comparing ICG-performed minimal invasive total thyroidectomy Identifying the cut-off points that predict low PTH levels (less than 20pg/ml) Identifying and analyzing problematic groups of patients The study is designed as a prospective observational multi-center study. Any patient that has indication for a total thyroidectomy will be considered eligible. The study will be conducted until 60 subjects are included. It is estimated that it will take up to 3 months to enroll the patients. Pre-Surgery: Procedures preformed such as routine hospital examinations, antibiotic prophylactic treatment, anticoagulant treatment and diet will be according to the standard management protocol and will be recorded for the study. The following pre-surgery information will be recorded: Demographic information including: name, age, gender, ethnicity Height, weight, BMI and American Society of Anesthesiologists physical status classification system (I-VI) Behavioral history (Smoking, alcohol or drug use) Preoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH, VitD) Diagnosis including clinical observations and previous imaging results Pre-operative characteristics of the adenoma Medications Current and past history of surgical and medical comorbidities Intra-operative: The surgeon will perform the preplanned operation. 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 ICG score (ranging from 1 to 3 [5]) for each grand Pathology data form: The following pathology data will be recorded for all patients: Post-operative diagnosis including pathology report Possible parathyroids excised Postoperative follow-up: Follow-up evaluation will be performed during hospitalization 1 Postoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH)

Official Title
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Does Indocyanine Imaging Scoring Predicts Postoperative PTH Levels at 24 Hours After Total Thyroidectomy

Conditions
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Thyroid, Parathyroid; Deficiency

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is over 18 years old Patient scheduled for a non-emergency operation Patient eligible for total thyroidectomy Exclusion Criteria: Patient is participating in another clinical trial which may affect this study's outcomes Prior operation in the neck Primary or secondary hyperparathyroidism Vitamin D deficiency Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>The group will include all adult patients that will sign ICF and will be operated for total thyroidectomy regardless of the undelying disease | Drug: Indocyanine Green<br>* Indocyanine green will be administered intravenously to patients enrolled in this study after the completion of total thyroidectomy in order to assess the visibility of parathyroid glands and to assess the possible correlation of ICG score with post-operative parathormone levels in order to predict post-thyroidectomy hypoparathyroidism.<br>* Other names: indocyanine green solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative ICG fluarangiography predicts post-operative PTH values | Whether ICG score of parathyroid glands after total thyroidectomy correlates with 24 post-operative values of PTH | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICG improves the intraoperative recognizability of the parathyroids | To assess the ability of ICG flurangiography to increase recognizability of parathyroid glands during total thyroidectomy based on ICG score of the parathyroids. | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indocyanine Green, Near Infrared Imaging, Total Thyroidectomy