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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516255-41-00
Acronym
29BRC20.0208
Enrollment
242
Registered
2024-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Diseases Hypoparathyroidism Hypocalcemia

Brief summary

Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery

Detailed description

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

Interventions

Sponsors

Centre Hospitalier Regional Et Universitaire De Brest
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery

Secondary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026