Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
Primary Purpose
Hypoparathyroidism Postprocedural, Hypocalcemia, Surgery--Complications
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
NIR optical imaging camera
Sponsored by
About this trial
This is an interventional prevention trial for Hypoparathyroidism Postprocedural focused on measuring thyroide surgery, total thyroidectomy, compltion thyroidectomy, parathyroidectomy, autofluorescense, NIR, near-infrared, optical imaging
Eligibility Criteria
Inclusion Criteria:
- Able to understand patient information and to give written informed consent
- Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.
Exclusion Criteria:
- Not able to understand patient information and to give written informed consent
- Previous parathyroid surgery or other parathyroid decease
- Age under 18
Sites / Locations
- RigshospitaletRecruiting
- Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, DenmarkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Plus NIR optical imaging
Minus NIR optical imaging
Arm Description
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery
Conventional identification of parathyroid glands during thyroid surgery
Outcomes
Primary Outcome Measures
Postoperative hypoparathyroidism
Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline
Secondary Outcome Measures
Postoperative hypocalcemia
Hypocalcemia defined as: ionized Calcium < 1,15 mmol/L
Time
Duration of surgery
Parathyroidglands identified by NIR light
Number of identified by NIR light vs. white light
Full Information
NCT ID
NCT04193332
First Posted
December 6, 2019
Last Updated
January 31, 2022
Sponsor
Rigshospitalet, Denmark
Collaborators
Cluster for molecular imaging, Denmark, Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04193332
Brief Title
Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
Official Title
Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Cluster for molecular imaging, Denmark, Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to:
Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence.
Control: Conventional thyroidectomy and parathyroid identification by the surgeon.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoparathyroidism Postprocedural, Hypocalcemia, Surgery--Complications
Keywords
thyroide surgery, total thyroidectomy, compltion thyroidectomy, parathyroidectomy, autofluorescense, NIR, near-infrared, optical imaging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plus NIR optical imaging
Arm Type
Experimental
Arm Description
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery
Arm Title
Minus NIR optical imaging
Arm Type
No Intervention
Arm Description
Conventional identification of parathyroid glands during thyroid surgery
Intervention Type
Device
Intervention Name(s)
NIR optical imaging camera
Intervention Description
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
Primary Outcome Measure Information:
Title
Postoperative hypoparathyroidism
Description
Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline
Time Frame
24 months-follow-up
Secondary Outcome Measure Information:
Title
Postoperative hypocalcemia
Description
Hypocalcemia defined as: ionized Calcium < 1,15 mmol/L
Time Frame
12 months follow-up
Title
Time
Description
Duration of surgery
Time Frame
Immediately after surgery
Title
Parathyroidglands identified by NIR light
Description
Number of identified by NIR light vs. white light
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand patient information and to give written informed consent
Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.
Exclusion Criteria:
Not able to understand patient information and to give written informed consent
Previous parathyroid surgery or other parathyroid decease
Age under 18
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Lykke, MD
Phone
+45 35454799
Email
eva.lykke@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Christensen, MD, PhD
Phone
+45 35459786
Email
anders.christensen.03@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian von Buchwald, MDSc, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Lykke, MD
Phone
+45 35454799
Email
eva.lykke@regionh.dk
First Name & Middle Initial & Last Name & Degree
Christian on Buchwald, MDSc, PhD
Phone
+45 35452370
Email
christian.von.buchwald@regionh.dk
Facility Name
Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Preben Homøe, DMSc, PhD
Phone
+45 56 63 15 00
Email
prho@regionsjaelland.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30527238
Citation
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.
Results Reference
background
PubMed Identifier
30710614
Citation
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.
Results Reference
background
PubMed Identifier
29122325
Citation
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.
Results Reference
background
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Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
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