Hypoparathyroidism PostproceduralNCT04193332
Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
A study testing NIR optical imaging camera in people with Hypoparathyroidism Postprocedural and Hypocalcemia, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism Postprocedural, Hypocalcemia, Surgery--Complications
- What is being tested?
- NIR optical imaging camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Aug 2019to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand patient information and to give written informed consent
- Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.
Who cannot join
- Not able to understand patient information and to give written informed consent
- Previous parathyroid surgery or other parathyroid decease
- Age under 18
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Eva Lykke, MD, +45 35454799, eva.lykke@regionh.dk
Christian on Buchwald, MDSc, PhD, +45 35452370, christian.von.buchwald@regionh.dk
- Recruiting
Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
Køge, 4600
Preben Homøe, DMSc, PhD, +45 56 63 15 00, prho@regionsjaelland.dk
About this study
Official title: Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism
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.
Read the 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.
- Being tested
- NIR optical imaging camera
- Keywords
- thyroide surgery, total thyroidectomy, compltion thyroidectomy, parathyroidectomy, autofluorescense, NIR, near-infrared, optical imaging
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIR optical imaging cameraDevice
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
| Study group | Role | What they receive |
|---|---|---|
| Plus NIR optical imaging | Experimental | NIR optical imaging assisted identification of parathyroid glands during thyroid surgery Receives: Device: NIR optical imaging camera |
| Minus NIR optical imaging | No intervention | Conventional identification of parathyroid glands during thyroid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hypoparathyroidism
Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline
Measured: 24 months-follow-up
Secondary outcomes (3)
Postoperative hypocalcemia
Hypocalcemia defined as: ionized Calcium < 1,15 mmol/L
Measured: 12 months follow-up
Time
Duration of surgery
Measured: Immediately after surgery
Parathyroidglands identified by NIR light
Number of identified by NIR light vs. white light
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start16 Aug 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypoparathyroidism PostproceduralStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Cluster for molecular imaging, Denmark, Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
- Responsible party
- Principal investigator, Eva Lykke, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian von Buchwald, MDSc, PhD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193332
- Sponsor's protocol ID
- H19010211
- Status last verified
- Jan 2022
- First submitted
- 6 Dec 2019
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30527238Dip 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.
PubMed 30710614Benmiloud 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.
PubMed 29122325Lykke 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.
PubMed 36853388
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT04193332
- Acronym / sponsor ID
- H19010211
- Keywords
- thyroide surgery, total thyroidectomy, compltion thyroidectomy, parathyroidectomy, autofluorescense, NIR, near-infrared, optical imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Cluster for molecular imaging, Denmark, Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plus NIR optical imaging | Experimental | Device: NIR optical imaging cameraNIR optical imaging assisted identification of parathyroid glands during thyroid surgery |
| Minus NIR optical imaging | No intervention | –Conventional identification of parathyroid glands during thyroid surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to understand patient information and to give written informed consent
- Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.
Key exclusion criteria (3 listed)
- Not able to understand patient information and to give written informed consent
- Previous parathyroid surgery or other parathyroid decease
- Age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIR optical imaging cameraNIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense | Device | Plus NIR optical imaging |
Primary outcome
Postoperative hypoparathyroidism
Time frame: 24 months-follow-up
Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline
3 secondary outcomes
Postoperative hypocalcemia
Time frame: 12 months follow-up
Time
Time frame: Immediately after surgery
Parathyroidglands identified by NIR light
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 30527238Abbaci 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.
- Background: PubMed 30710614Dip 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.
- Background: PubMed 29122325Benmiloud 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.
- Derived from this study: PubMed 36853388Lykke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian von Buchwald, MDSc, PhD study director
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIR optical imaging camera in people with Hypoparathyroidism Postprocedural and Hypocalcemia, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Lykke, MD (+45 35454799, eva.lykke@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hypoparathyroidism (time frame: 24 months-follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04193332, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.