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

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid; Parathyroid; Deficiency
• Intervention / Treatment: Drug: Indocyanine Green

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54621
    • 1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki
  • Please Enter The State Or Province
    • Thessaloniki, Please Enter The State Or Province, Greece, 54655
      • Unit of Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients that are going to have a total thyroidectomy regardless of the underlying pathology

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study group; 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; 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.; Other Names: indocyanine green solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Director: Theodosios S Papavramidis, PhD, Assistant professor of surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): April 26, 2019
• Study Completion (Actual): April 26, 2019

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Indocyanine Green; Near Infrared Imaging; Total Thyroidectomy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: ICG002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No