CHRU de Brest
Brest, 29609, France
Location status: Recruiting
Location contact
Gael POTARD
SUB_INVESTIGATOR
Jean-Christophe LECLERE
CONTACT
Julien PREVOT
SUB_INVESTIGATOR
NCT Number: NCT04785443
* 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Brest, 29609, France
Location status: Recruiting
Gael POTARD
SUB_INVESTIGATOR
Jean-Christophe LECLERE
CONTACT
Julien PREVOT
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Day 2
Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.
Time frame: Day 8, Month 1 and Month 6
Occurrence (yes/no) of albumin-corrected (<2mmol/L) postoperative hypocalcemia at D8, M1 and M6
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.
Time frame: Day 0
Intraoperative parathyroid vitality score (0=devascularized parathyroid gland to 2 = vascularized thyroid gland) when using indocyanine green angiography.
Time frame: Day 1 and Day 2
Occurrence (yes/no) of hypo parathormone at D1 and D2 postoperatively (<10ng/L).
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.
Time frame: Day 1, Day 2, Day 10
Occurrence of an adverse event related to the injection of indocyanine green.
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
Acronym: HYPOCAAVI
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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