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Impact of Intraoperative Arteriography with Indocyanine Green in Preserving the Parathyroid Glands During Total Thyroidectomy With or Without Central Cervical Lymph Node Dissection. A Multicenter Prospective Randomized Trial.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509130-18-00
Acronym
GUIARTE-HUB-2022
Enrollment
394
Registered
2024-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-29

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

Conditions

Hypothyroidism

Brief summary

Number (percentage) of PG preserved with intraoperative ICG arteriography and the number (percentage) of preserved PG without it.

Detailed description

Preoperative calcium, total protein, vitamin D, and PTH serum levels, Number of well perfused GP in situ, GP score according to the black and white system, Surgery duration, Intraoperative PTH serum level, Serum PTH, calcium, and total protein levels at 24h after surgery, Serum PTH levels 1, 3, 6 and 12 months after surgery, 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.

Interventions

DRUGINDOCYANINE GREEN

Sponsors

Bellvitge University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number (percentage) of PG preserved with intraoperative ICG arteriography and the number (percentage) of preserved PG without it.

Secondary

MeasureTime frame
Preoperative calcium, total protein, vitamin D, and PTH serum levels, Number of well perfused GP in situ, GP score according to the black and white system, Surgery duration, Intraoperative PTH serum level, Serum PTH, calcium, and total protein levels at 24h after surgery, Serum PTH levels 1, 3, 6 and 12 months after surgery, 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.

Countries

Spain

Outcome results

None listed

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