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

• ClinicalTrials.gov Identifier: NCT04785443
• Recruitment Status: Not yet recruiting
• First Posted: March 5, 2021
• Last Update Posted: March 5, 2021
• Sponsor: University Hospital, Brest
• Information provided by (Responsible Party): University Hospital, Brest

Tracking Information

• First Submitted Date: February 25, 2021
• First Posted Date: March 5, 2021
• Last Update Posted Date: March 5, 2021
• Estimated Study Start Date: April 2021
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
• Official Title: 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: Interventional
• Study Phase: Phase 3

Study Design

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: Thyroid Diseases

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 4, 2021): 242
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04785443
• Other Study ID Numbers: 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

• 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: University Hospital, Brest
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jean-Christophe LECLERE, PhD; CHRU de Brest

• PRS Account: University Hospital, Brest
• Verification Date: February 2021