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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03910049
Acronym
ICGPREDICT
Enrollment
60
Registered
2019-04-10
Start date
2018-12-03
Completion date
2019-04-26
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parathyroid; Deficiency, Thyroid

Keywords

Indocyanine Green, Near Infrared Imaging, Total Thyroidectomy

Brief summary

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

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: 1. Demographic information including: name, age, gender, ethnicity 2. Height, weight, BMI and American Society of Anesthesiologists physical status classification system (I-VI) 3. Behavioral history (Smoking, alcohol or drug use) 4. Preoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH, VitD) 5. Diagnosis including clinical observations and previous imaging results 6. Pre-operative characteristics of the adenoma 7. Medications 8. 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: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments 5. Number and location of the visualized glands 6. 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: 1. Post-operative diagnosis including pathology report 2. 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)

Interventions

DRUGIndocyanine Green

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.

Sponsors

Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Intra-operative ICG fluarangiography predicts post-operative PTH values24 hoursWhether ICG score of parathyroid glands after total thyroidectomy correlates with 24 post-operative values of PTH

Secondary

MeasureTime frameDescription
ICG improves the intraoperative recognizability of the parathyroidsIntraoperativeTo assess the ability of ICG flurangiography to increase recognizability of parathyroid glands during total thyroidectomy based on ICG score of the parathyroids.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026