Using special imaging techniques to prevent low calcium levels after thyroid surgery
The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial
PHASE3 · Onze Lieve Vrouw Hospital · NCT05117853
This study is testing if special imaging techniques during thyroid surgery can help doctors find and protect important glands to prevent low calcium levels after the operation.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Onze Lieve Vrouw Hospital (other) |
| Locations | 1 site (Aalst) |
| Trial ID | NCT05117853 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of autofluorescence and indocyanine green injection during total thyroidectomy to identify and preserve parathyroid glands, which are crucial for preventing postoperative hypocalcemia. The study aims to determine if these imaging techniques can enhance the detection of parathyroid glands and their vascular supply, thereby reducing the incidence of low calcium levels after surgery. By comparing outcomes in patients receiving these interventions against standard visual identification methods, the trial seeks to provide evidence for improved surgical practices in thyroid procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients undergoing total thyroidectomy without prior neck surgery.
Not a fit: Patients who have had previous neck surgery or those requiring lymph node dissections for thyroid cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of hypocalcemia following thyroid surgery, improving patient outcomes and quality of life.
How similar studies have performed: While the use of autofluorescence and indocyanine green is gaining interest, this specific combination in thyroid surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult patients undergoing a total thyroidectomy without previous neck surgery. Exclusion Criteria: * Children and teenagers (\<18 years old) * Patients refusing participation or unable/unwilling to sign the informed consent * Patients with a completion thyroidectomy * Patients with planned central and lateral neck lymph node dissections (thyroid cancer) * Patients with previous neck surgery * Patients with a known allergy/hypersensitivity to indocyanine green
Where this trial is running
Aalst
- Onze Lieve Vrouw Hospital — Aalst, Belgium (RECRUITING)
Study contacts
- Study coordinator: Klaas Van Den Heede, MD
- Email: klaasvandenheede@hotmail.com
- Phone: 0032472893861
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.
Conditions: Thyroid Disease, Hypoparathyroidism Postprocedural