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

NCT ID: NCT04785443

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2025-03-31

Brief Summary

• 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.

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.

Conditions

Thyroid Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ICG group

Patient receiving 2 or 3 intraoperative injections of indocyanine green.

Group Type: EXPERIMENTAL

ICG

Intervention Type: DRUG

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.

Control group

Patient benefiting from the traditional surgical act

Group Type: OTHER

Control group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Christophe LECLERE, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest

Locations

CHRU de Brest

Brest, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Christophe LECLERE, PhD

Role: CONTACT

jean-christophe.leclere@chu-brest.fr

0298223630 ext. +33

Facility Contacts

Jean-Christophe LECLERE

Role: primary

Other Identifiers

29BRC20.0208

Identifier Type: -

Identifier Source: org_study_id