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

NCT03910049 | Completed FDA Drug

• 1 other identifier: ICG002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Thyroid; Parathyroid; Deficiency

Keywords

Indocyanine Green; Near Infrared Imaging; Total Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ICG improves the intraoperative recognizability of the parathyroids

  Intraoperative

Study Arms (1)

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

Interventions

Indocyanine Green DRUG

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.

Also known as: indocyanine green solution

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient is over 18 years old
• Patient scheduled for a non-emergency operation
• Patient eligible for total thyroidectomy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (2)

Unit of Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece

Thessaloniki, Please Enter the State Or Province, 54655, Greece

Location

1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki

Thessaloniki, 54621, Greece

Location

MeSH Terms

Conditions

Thyroid Diseases; Hypoparathyroidism

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Parathyroid Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Theodosios S Papavramidis, PhD

  Assistant Professor of Surgery

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Surgery

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: April 10, 2019
• Study Start: December 3, 2018
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

GR (2)