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

Completed

• Conditions: Thyroid; Parathyroid; Deficiency
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT03910049
• Lead Sponsor: Aristotle University Of Thessaloniki

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)

Study Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Primary Completion: 2019-04-26
• Study Completion: 2019-04-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Indocyanine Green	The group will include all adult patients that will sign ICF and will be operated for total thyroidectomy regardless of the undelying disease

Primary Outcome Measures

Name	Time	Method
Intra-operative ICG fluarangiography predicts post-operative PTH values	24 hours	Whether ICG score of parathyroid glands after total thyroidectomy correlates with 24 post-operative values of PTH

Secondary Outcome Measures

Name	Time	Method
ICG improves the intraoperative recognizability of the parathyroids	Intraoperative	To assess the ability of ICG flurangiography to increase recognizability of parathyroid glands during total thyroidectomy based on ICG score of the parathyroids.

Trial Locations

Locations (2)

1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Unit of Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece; 🇬🇷 Thessaloniki, Please Enter The State Or Province, Greece