Using ICG Angiography to Improve Thyroid Surgery Outcomes
Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.
This study is testing if using a special imaging technique during thyroid surgery can help protect parathyroid function and reduce the risk of low hormone levels after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 394 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 2 sites (L'Hospitalet de Llobregat, Barcelona and 1 other locations) |
| Trial ID | NCT05573828 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of indocyanine green (ICG) angiography in preserving parathyroid function during total thyroidectomy. Patients undergoing thyroid surgery will be divided into two groups: one receiving ICG angiography to visualize the vascular map of the parathyroid glands before surgery, and the other not receiving this intervention. The primary outcome will be the incidence of postoperative hypoparathyroidism, assessed through measurements of parathyroid hormone and calcium levels. The goal is to determine if ICG-guided surgery leads to better preservation of parathyroid function compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require total thyroidectomy due to thyroid pathology.
Not a fit: Patients with previous thyroid or parathyroid surgery, or those with conditions requiring parathyroidectomy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of hypoparathyroidism following thyroid surgery, improving patient outcomes.
How similar studies have performed: While the use of ICG in surgical settings is gaining traction, this specific application for thyroid surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 pathology. * The patient or their guardian, where applicable, has the capacity to understand the study and agrees to participate in it, signing the corresponding informed consent document. Exclusion Criteria: * Previous surgical intervention on the thyroid or parathyroid gland. * Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act. * Patients with contraindications for the administration of ICG. * Current drug use or alcohol abuse that could interfere with compliance with the study requirements. * Participation in any other drug trials in the month prior to randomization.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona and 1 other locations
- Hospital UIniversitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Pablo Moreno Llorente — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Pablo Moreno — Hospital Universitari de Bellvitge
- Study coordinator: Pablo Moreno
- Email: 25108pml@gmail.com
- Phone: 661214772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.