Clinical trial NCT03910049: Does Indocyanine Imaging Scoring Predicts Postoperative Parathormone Levels at 24 Hours After Total Thyroidectomy
Official title: Does Indocyanine Imaging Scoring Predicts Postoperative PTH Levels at 24 Hours After Total Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid
Parathyroid; Deficiency
Keywords: Indocyanine Green
Near Infrared Imaging
Total Thyroidectomy
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that are going to have a total thyroidectomy regardless of the underlying pathology

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Intra-operative ICG fluarangiography predicts post-operative PTH values
timeFrame: 24 hours
Secondary outcomes:
measure: ICG improves the intraoperative recognizability of the parathyroids
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit of Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece
state: Please Enter The State Or Province
city: Thessaloniki
country: Greece
facility: 1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki
Study officials:
affiliation: Assistant Professor of Surgery
name: Theodosios S Papavramidis, PhD
role: STUDY_DIRECTOR
References: