Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG group | Experimental | Patient receiving 2 or 3 intraoperative injections of indocyanine green. |
|
| Control group | Other | Patient benefiting from the traditional surgical act |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Christophe LECLERE, PhD | Contact | 0298223630 | +33 | jean-christophe.leclere@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Christophe LECLERE, PhD | CHRU de Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest | Recruiting | Brest | 29609 | France |
All collected data that underlie results in a publication.
Data will be available beginning three years and ending fifteen years following the final study report completion.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D006996 | Hypocalcemia |
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Monocentric, comparative, randomized, single-blind, controlled trial against the reference method
Not provided
Not provided
Simple blind (only participant)
|
| 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. |
|
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 |
| D014883 | Water-Electrolyte Imbalance |
| D010279 | Parathyroid Diseases |
| D008722 | Methods |