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

Thyroid Clinical Trial

— ICGPREDICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03910049
• Other study ID #: ICG002
• Status: Completed
• Start date: December 3, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: August 2019
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypoparathyroidism
• Parathyroid; Deficiency
• Thyroid

Intervention

Drug:
• Indocyanine 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.

Locations

Country	Name	City	State
Greece	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

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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