INDOCYANINE GREEN for Hypothyroidism|Hypoparathyroidism

Inclusion criteria

• {"criterion_text":"- Patients ≥18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid disease."}
• {"criterion_text":"- The patient or legal guardian can understand the study and agrees to participate by signing the written informed consent."}

Exclusion criteria

• {"criterion_text":"- Previous surgical intervention on the thyroid or parathyroid gland."}
• {"criterion_text":"- Evidence of associated hyperparathyroidism requiring a parathyroidectomy in the same surgical procedure."}
• {"criterion_text":"- Patients with known contraindications to ICG."}

Primary endpoints

• {"endpoint_text":"- Number (percentage) of PG preserved with intraoperative ICG arteriography and the number (percentage) of preserved PG without it.","definition_or_measurement_approach":"Measured as the number and percentage of parathyroid glands (PG) preserved in each arm: with intraoperative ICG arteriography versus without ICG arteriography."}

Secondary endpoints

• {"endpoint_text":"- Preoperative calcium, total protein, vitamin D, and PTH serum levels","definition_or_measurement_approach":"Measured as laboratory serum values of total calcium, total protein, vitamin D and PTH prior to surgery."}
• {"endpoint_text":"- Number of well perfused GP in situ","definition_or_measurement_approach":"Count of parathyroid glands assessed intraoperatively as well perfused (in situ)."}
• {"endpoint_text":"- GP score according to the black and white system","definition_or_measurement_approach":"Scoring of parathyroid gland perfusion using the black and white system as defined in the protocol."}
• {"endpoint_text":"- Surgery duration","definition_or_measurement_approach":"Measured as operative time (duration of surgery)."}
• {"endpoint_text":"- Intraoperative PTH serum level","definition_or_measurement_approach":"Measurement of parathyroid hormone (PTH) levels during the operation."}
• {"endpoint_text":"- Serum PTH, calcium, and total protein levels at 24h after surgery","definition_or_measurement_approach":"Laboratory measurement of serum PTH, calcium and total protein at 24 hours post-operation."}
• {"endpoint_text":"- Serum PTH levels 1, 3, 6 and 12 months after surgery","definition_or_measurement_approach":"Laboratory measurement of serum PTH at 1, 3, 6 and 12 months post-operation."}
• {"endpoint_text":"- Presence or absence of hypoparathyroidism during the one-year follow-up. Hypoparathyroidism is defined as undetectable or inappropriately low serum PTH levels in the context of hypocalcemia.","definition_or_measurement_approach":"Determined during one-year follow-up by serum PTH and calcium: hypoparathyroidism defined as undetectable or inappropriately low PTH in the context of hypocalcemia."}

Spain

Earliest CTIS Part Ii Submission Date

23-12-2023

Latest Decision Or Authorization Date

24-01-2024

Processing Time Days

32

Number Of Sites

3

Number Of Participants

394

Primary sponsor

Full Name

Bellvitge University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain