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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 : Not yet recruiting
First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE February 25, 2021
First Posted Date  ICMJE March 5, 2021
Last Update Posted Date March 5, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
  • 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
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
Official Title  ICMJE Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Thyroid Diseases
Intervention  ICMJE
  • Drug: ICG

    During thyroidectomy surgery, the patient will received 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 at the end of the dissection.

    Patients will then be followed during 6 months.

  • 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.

Study Arms  ICMJE
  • Experimental: ICG group
    Patient receiving 3 intraoperative injections of indocyanine green.
    Intervention: Drug: ICG
  • Control group
    Patient benefiting from the traditional surgical act
    Intervention: Procedure: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2021)
242
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Christophe LECLERE, PhD 0298223630 ext +33 jean-christophe.leclere@chu-brest.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04785443
Other Study ID Numbers  ICMJE 29BRC20.0208
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Christophe LECLERE, PhD CHRU de Brest
PRS Account University Hospital, Brest
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP