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

NCT04785443 | Recruiting Phase 3

• 1 other identifier: 29BRC20.0208
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Diseases

Keywords

Hypocalcemia; Hypoparathyroidism; Angiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluate the contribution of ICG angiography in the modification of the rate of definitive hypoparathyroidism after total thyroidectomy.

  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.

  Day 0

• To evaluate the contribution of indocyanine green angiography in the prediction of postoperative hypocalcemia.

  Day 0

• To determine the interest of indocyanine green angiography (ICG) in the prediction of hypoparathyroidism after total thyroidectomy.

  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.

  D1 and D2

Study Arms (2)

ICG group

EXPERIMENTAL

Patient receiving 2 or 3 intraoperative injections of indocyanine green.

Drug: ICG

Control group

OTHER

Patient benefiting from the traditional surgical act

Procedure: Control group

Interventions

ICG 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.

ICG group

Control group 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.

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases; Hypocalcemia; Hypoparathyroidism

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Parathyroid Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jean-Christophe LECLERE, PhD

  CHRU de Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Christophe LECLERE, PhD

CONTACT

0298223630; jean-christophe.leclere@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Simple blind (only participant)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, comparative, randomized, single-blind, controlled trial against the reference method

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 5, 2021
• Study Start: June 22, 2021
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): June 22, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
• 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.

Locations

FR (1)