2024-516255-41-00
Not yet recruiting
Phase 3
Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy (HYPOCAAVI)
Centre Hospitalier Regional Et Universitaire De Brest1 site in 1 country242 target enrollmentJuly 31, 2024
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
Compare the incidence of albumin-corrected hypocalcaemia (blood calcium less than 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the group using indocyanine green and the group not using indocyanine green.
Investigators
Dr Jean-Christophe LECLERE
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
Eligibility Criteria
Inclusion Criteria
- •Patients requiring total thyroidectomy
- •Signed consent
- •Patient covered by a social security scheme
Exclusion Criteria
- •Patients under 18 years of age
- •Protected adult or person incapable of giving consent to the study
- •Pregnant and breast-feeding women
- •Total thyroidectomy (removal of the remaining thyroid lobe in a patient who has already had a hemi thyroidectomy)
- •Previous thyroid or parathyroid surgery
- •Refusal to participate
- •Known allergic reaction to indocyanine green (ICG)
- •Women of childbearing age not using an adequate method of contraception
Outcomes
Primary Outcomes
Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery
Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery
Secondary Outcomes
- Occurrence (yes/no) of post-operative hypocalcaemia corrected by albumin (<2mmol/L) at D8, M1 and M6
- Modification (yes/no) of the surgical procedure by improving detection of the parathyroids or their vascularisation during thyroidectomy with the use of indocyanine green angiography
- Intraoperative parathyroid vitality score when using indocyanine green angiography
- Occurrence (yes/no) of hypoPTH on D1 and D2 post-op (<10ng/L)
- Occurrence (yes/no) of mild (asymptomatic and >1.7mmol/l), moderate (symptomatic and >1.7mmol/l) and profound (<1.7mmol/l) hypocalcaemia in the 48 postoperative hours
- Occurrence of an adverse reaction linked to the injection of indocyanine green
Study Sites (1)
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