Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy (HYPOCAAVI)

Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy

• Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It becomes permanent after 6 months.
• Untreated permanent hypoparathyroidism is a source of numerous complications in general and therefore requires lifelong replacement therapy resulting in a significant deterioration in quality of life.
• The intraoperative use of indocyanine green (ICG) angiography has recently been described as a reliable means of detecting parathyroidism and predicting the risk of postoperative hypoparathyroidism.
• This use could prove to be a way to preserve parathyroid in vivo and thus reduce post-operative hypoparathyroidism rates.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Diseases
• Intervention / Treatment: Drug: ICG; Procedure: Control group

Detailed Description

Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It is most often transient but can sometimes be permanent when it persists for more than 6 months after surgery. The rates are variable, of the order of 32% for transient hypoparathyroidism and 1% for definitive hypoparathyroidism. Untreated permanent hypoparathyroidism is the source of many complications in general and therefore requires lifelong replacement therapy. The result is a significant deterioration in quality of life.

The mechanisms responsible for hypoparathyroidism during thyroidectomy are direct damage to the parathyroid glands, involuntary excision of these glands, and devascularization of these glands.

The detection of parathyroid glands and the prevention of hypoparathyroidism after thyroidectomy therefore represents a major challenge.

The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative hypoparathyroidism.

In addition, prior studies and intraoperative observations suggest that indocyanine green angiography during thyroid surgery may be a means of preserving parathyroid in vivo and thus reducing post-operative hypoparathyroidism rates.

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jean-Christophe LECLERE, PhD; Phone Number: +33 0298223630; Email: jean-christophe.leclere@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Jean-Christophe LECLERE
    • Sub-Investigator: Gael POTARD
    • Sub-Investigator: Julien PREVOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient having to undergo a total thyroidectomy
• Signed consent
• Patient beneficiary of a social security regimen

Exclusion Criteria:

• Minor patient under 18 years old
• Major patient protected by law or unable to give informed consent
• Pregnant or breastfeeding woman
• Thyroidectomy totalization
• History of thyroid or parathyroid surgery
• Participation refusal
• Known allergy to ICG
• Woman of child-bearing age not using adequate method of contraception

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICG group; Patient receiving 2 or 3 intraoperative injections of indocyanine green.	Drug: ICG; During thyroidectomy surgery, the patient will received 2 or 3 injections of 5 mg as a bolus. The first one during the dissection of the first lobe, then during the dissection of the second lobe and finally if needed, a 3rd injection will be done at the end of the dissection. Patients will then be followed during 6 months.
Other: Control group; Patient benefiting from the traditional surgical act	Procedure: Control group; During thyroidectomy surgery, patients are treated according to traditional surgery with detection of parathyroids with the naked eyes. Patients will then be followed during 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the frequency of albumin-corrected hypocalcemia (blood sugar below 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the ICG group and the control group.	Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the contribution of ICG angiography in the modification of the rate of definitive hypoparathyroidism after total thyroidectomy.	Occurrence (yes/no) of albumin-corrected (<2mmol/L) postoperative hypocalcemia at D8, M1 and M6	Day 8, Month 1 and Month 6
Determine the contribution of indocyanine green angiography (ICG) during the total thyroidectomy procedure for in vivo detection and preservation of parathyroid glands.	Modification (yes/no) of the surgical procedure by improving the detection of parathyroids or their vascularization during thyroidectomy with the use of indocyanine green angiography.	Day 0
To evaluate the contribution of indocyanine green angiography in the prediction of postoperative hypocalcemia.	Intraoperative parathyroid vitality score (0=devascularized parathyroid gland to 2 = vascularized thyroid gland) when using indocyanine green angiography.	Day 0
To determine the interest of indocyanine green angiography (ICG) in the prediction of hypoparathyroidism after total thyroidectomy.	Occurrence (yes/no) of hypo parathormone at D1 and D2 postoperatively (<10ng/L).	Day 1 and Day 2
Compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate and deep), between the ICG group and the control group.	Frequency of mild (asymptomatic and >1.7mmol/l), moderate (symptomatic and >1.7mmol/l) and profound (<1.7mmol/l) hypocalcemia within 48 hours postoperatively.	D1 and D2
Evaluate the tolerance of indocyanine green.	Occurrence of an adverse event related to the injection of indocyanine green.	Day 1, Day 2, Day 10

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Jean-Christophe LECLERE, PhD, CHRU de Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Hypocalcemia; Hypoparathyroidism; Angiography
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Thyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: 29BRC20.0208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication.
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
• IPD Sharing Access Criteria: Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No