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.
Phase 1
- Conditions
- HypothyroidismMedDRA version: 20.0Level: PTClassification code: 10062127Term: Thyroidectomy Class: 100000004865MedDRA version: 20.0Level: PTClassification code: 10021041Term: Hypoparathyroidism Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Registration Number
- CTIS2023-509130-18-00
- Lead Sponsor
- Bellvitge University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 394
Inclusion Criteria
Patients =18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid disease., The patient or legal guardian can understand the study and agrees to participate by signing the written informed consent.
Exclusion Criteria
Previous surgical intervention on the thyroid or parathyroid gland., Evidence of associated hyperparathyroidism requiring a parathyroidectomy in the same surgical procedure., Patients with known contraindications to ICG.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method