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NCT Number: NCT04785443

Contribution of ICG 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU de Brest

Brest, 29609, France

Location status: Recruiting

Location contact

Gael POTARD

SUB_INVESTIGATOR

Jean-Christophe LECLERE

CONTACT

Julien PREVOT

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

    Time frame: Day 2

    Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.

Secondary outcomes

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

    Time frame: Day 8, Month 1 and Month 6

    Occurrence (yes/no) of albumin-corrected (<2mmol/L) postoperative hypocalcemia at D8, M1 and M6

  2. Determine the contribution of indocyanine green angiography (ICG) during the total thyroidectomy procedure for in vivo detection and preservation of parathyroid glands.

    Time frame: Day 0

    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.

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

    Time frame: Day 0

    Intraoperative parathyroid vitality score (0=devascularized parathyroid gland to 2 = vascularized thyroid gland) when using indocyanine green angiography.

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

    Time frame: Day 1 and Day 2

    Occurrence (yes/no) of hypo parathormone at D1 and D2 postoperatively (<10ng/L).

  5. Compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate and deep), between the ICG group and the control group.

    Time frame: D1 and D2

    Frequency of mild (asymptomatic and >1.7mmol/l), moderate (symptomatic and >1.7mmol/l) and profound (<1.7mmol/l) hypocalcemia within 48 hours postoperatively.

  6. Evaluate the tolerance of indocyanine green.

    Time frame: Day 1, Day 2, Day 10

    Occurrence of an adverse event related to the injection of indocyanine green.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Christophe LECLERE, PhD

CONTACT

[email protected]

0298223630 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: HYPOCAAVI

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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