Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
1 other identifier
interventional
214
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2019
CompletedFirst Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 14, 2022
January 1, 2022
4.1 years
December 6, 2019
January 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative hypoparathyroidism
Hypoparathyroidism defined as: PTH \< 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline
24 months-follow-up
Secondary Outcomes (3)
Postoperative hypocalcemia
12 months follow-up
Time
Immediately after surgery
Parathyroidglands identified by NIR light
During surgery
Study Arms (2)
Plus NIR optical imaging
EXPERIMENTALNIR optical imaging assisted identification of parathyroid glands during thyroid surgery
Minus NIR optical imaging
NO INTERVENTIONConventional identification of parathyroid glands during thyroid surgery
Interventions
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
Eligibility Criteria
You may qualify if:
- Able to understand patient information and to give written informed consent
- Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.
You may not qualify if:
- Not able to understand patient information and to give written informed consent
- Previous parathyroid surgery or other parathyroid decease
- Age under 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rigshospitalet
Copenhagen, 2100, Denmark
Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
Køge, 4600, Denmark
Related Publications (4)
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.
PMID: 30527238BACKGROUNDDip 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.
PMID: 30710614BACKGROUNDBenmiloud 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.
PMID: 29122325BACKGROUNDLykke 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.
PMID: 36853388DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christian von Buchwald, MDSc, PhD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 6, 2019
First Posted
December 10, 2019
Study Start
August 16, 2019
Primary Completion
October 1, 2023
Study Completion
December 1, 2023
Last Updated
February 14, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share