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

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ClinicalTrials.gov Identifier: NCT04785443
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
Thyroid Diseases Drug: ICG Procedure: Control group Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Monocentric, comparative, randomized, single-blind, controlled trial against the reference method
Masking: Single (Participant)
Masking Description: Simple blind (only participant)
Primary Purpose: Prevention
Official Title: Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICG group
Patient receiving 2 or 3 intraoperative injections of indocyanine green.
Drug: 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.


Control group
Patient benefiting from the traditional surgical act
Procedure: 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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04785443


Contacts
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Contact: Jean-Christophe LECLERE, PhD 0298223630 ext +33 jean-christophe.leclere@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Jean-Christophe LECLERE         
Sub-Investigator: Gael POTARD         
Sub-Investigator: Julien PREVOT         
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Jean-Christophe LECLERE, PhD CHRU de Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04785443    
Other Study ID Numbers: 29BRC20.0208
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Hypocalcemia
Hypoparathyroidism
Angiography
Additional relevant MeSH terms:
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Hypoparathyroidism
Thyroid Diseases
Parathyroid Diseases
Endocrine System Diseases