Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cluster for molecular imaging, Denmark | UNKNOWN |
| Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.
Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to:
Measurements:
PTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up.
Anticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up.
An interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plus NIR optical imaging | Experimental | NIR optical imaging assisted identification of parathyroid glands during thyroid surgery |
|
| Minus NIR optical imaging | No Intervention | Conventional identification of parathyroid glands during thyroid surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIR optical imaging camera | Device | NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hypoparathyroidism | Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline | 24 months-follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hypocalcemia | Hypocalcemia defined as: ionized Calcium < 1,15 mmol/L | 12 months follow-up |
| Time | Duration of surgery | Immediately after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Lykke, MD | Contact | +45 35454799 | eva.lykke@regionh.dk | |
| Anders Christensen, MD, PhD | Contact | +45 35459786 | anders.christensen.03@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Christian von Buchwald, MDSc, PhD | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30527238 | Background | Abbaci M, De Leeuw F, Breuskin I, Casiraghi O, Lakhdar AB, Ghanem W, Laplace-Builhe C, Hartl D. Parathyroid gland management using optical technologies during thyroidectomy or parathyroidectomy: A systematic review. Oral Oncol. 2018 Dec;87:186-196. doi: 10.1016/j.oraloncology.2018.11.011. Epub 2018 Nov 16. | |
| 30710614 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Parathyroidglands identified by NIR light | Number of identified by NIR light vs. white light | During surgery |
| Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark | Recruiting | Køge | 4600 | Denmark |
|
| Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31. |
| 29122325 | Background | Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6. |
| 36853388 | Derived | Lykke E, Christensen A, Juhl K, Feldt-Rasmussen U, Friberg Hitz M, Svenningsen Sjostedt SM, Holst Hahn C, Kraik Svensson DM, Kanstrup Springborg K, Stage MG, Bjorn Hvilsom G, Hilsted LM, Dahl M, Lelkaitis G, Kjaer A, Homoe P, von Buchwald C. Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2023 May;280(5):2593-2603. doi: 10.1007/s00405-023-07867-4. Epub 2023 Feb 28. |