INDOCYANINE GREEN for Thyroid diseases | Hypoparathyroidism | Hypocalcemia

Inclusion criteria

• {"criterion_text":"- Patients requiring total thyroidectomy"}
• {"criterion_text":"- Signed consent"}
• {"criterion_text":"- Patient covered by a social security scheme"}

Exclusion criteria

• {"criterion_text":"- Patients under 18 years of age"}
• {"criterion_text":"- Protected adult or person incapable of giving consent to the study"}
• {"criterion_text":"- Pregnant and breast-feeding women"}
• {"criterion_text":"- Total thyroidectomy (removal of the remaining thyroid lobe in a patient who has already had a hemi thyroidectomy)"}
• {"criterion_text":"- Previous thyroid or parathyroid surgery"}
• {"criterion_text":"- Refusal to participate"}
• {"criterion_text":"- Known allergic reaction to indocyanine green (ICG)"}
• {"criterion_text":"- Women of childbearing age not using an adequate method of contraception"}

Primary endpoints

• {"endpoint_text":"- Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery","definition_or_measurement_approach":"Albumin-corrected blood calcium measurement; threshold ≤2 mmol/L assessed within 48 postoperative hours (occurrence yes/no)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence (yes/no) of post-operative hypocalcaemia corrected by albumin (<2mmol/L) at D8, M1 and M6","definition_or_measurement_approach":"Albumin-corrected blood calcium measured at Day 8, Month 1 and Month 6; threshold <2 mmol/L (occurrence yes/no)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessment of whether surgical procedure was modified intraoperatively due to improved detection/vascularisation of parathyroids with ICG (yes/no)."}
• {"endpoint_text":"- Intraoperative parathyroid vitality score when using indocyanine green angiography","definition_or_measurement_approach":"Use of an intraoperative parathyroid vitality score measured during surgery when ICG angiography is used (score-based measurement)."}
• {"endpoint_text":"- Occurrence (yes/no) of hypoPTH on D1 and D2 post-op (<10ng/L)","definition_or_measurement_approach":"Measurement of parathyroid hormone (PTH) on Day 1 and Day 2 post-op; threshold <10 ng/L (occurrence yes/no)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Classification of hypocalcaemia within 48 hours post-op by calcium level and symptoms: mild (asymptomatic and >1.7 mmol/L), moderate (symptomatic and >1.7 mmol/L), profound (<1.7 mmol/L)."}
• {"endpoint_text":"- Occurrence of an adverse reaction linked to the injection of indocyanine green","definition_or_measurement_approach":"Recording of adverse reactions temporally associated with ICG injection (occurrence documented)."}

France

Earliest CTIS Part Ii Submission Date

08-07-2024

Latest Decision Or Authorization Date

31-07-2024

Processing Time Days

23

Number Of Sites

1

Number Of Participants

242

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France