The use of Near-Infrared Fluorescence Imaging in parathyroid visualization during Thyroid Surgery: a pilot study

Recruiting

Conditions: thyroid disease
10043739
10014705

Registration Number: NL-OMON45992

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

• Male or female patients, aged 18 years and above
• Scheduled for elective total or hemi thyroidectomy
• Normal liver and renal function
• No known hypersensitivity for iodine, ICG, sulfa- or penicillin allergy
• Able to understand the nature of the study procedures
• Willing to participate and give written informed consent

Exclusion Criteria

• Age < 18 years
• Liver or renal insufficiency
• Known iodide, ICG, sulfa- or penicillin hypersensitivity
• Pregnancy or breastfeeding
• Not able to understand the nature of the study procedure
• i.v. heparine injection in the last 24h (LMWH not contraindicated)
• Not willing to participate

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main goal of this pilot study is to investigate the feasibility of<br /><br>identification of the parathyroid glands with fluorescence imaging equipment<br /><br>with per-operative ICG administration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Angiography of the parathyroid glands after resection of thyroid.<br /><br>Quantitative measurement of fluorescence signal using Target to Background<br /><br>Ratio (TBR)<br /><br>Calcium levels postoperatively day 1 and day 2 and after two weeks after total<br /><br>thyroidectomy<br /><br>PTH levels postoperatively after two weeks after total thyroidectomy<br /><br>Histology: are parathyroid glands in the specimen?<br /><br>Subjective opinion surgeon about the usefulness of the technique<br /><br>Time measurement:<br /><br>* Time until identification of first parathyroid gland<br /><br>* Time until identification of all four parathyroid glands<br /><br>* Total operation time (time from incision till closure)<br /><br>Differences between the two used systems (Karl Storz and Quest Medical Imaging)<br /><br>Intraoperative complications due to the use of the technique</p><br>