Hypoparathyroidism PostproceduralNCT05130476
Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Thyroidectomy
A study testing Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography in people with Hypoparathyroidism Postprocedural, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The parathyroid glands and their blood vessels are notoriously difficult to visualize and may therefore be unintentionally and irrevocably damaged during thyroid surgery. This project investigates new surgeon-performed imaging techniques that visualize the parathyroid glands and their vessels in real-time during… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoparathyroidism Postprocedural
- What is being tested?
- Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2021to 20 Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years and older who are scheduled to undergo total or completion thyroidectomy at the department of Oro-Rhino-Laryngology (ORL) and Head and Neck Surgery at Odense University Hospital, Denmark.
Who cannot join
- Not legally competent.
- Does not read or speak Danish.
- Is pregnant or nursing.
- Suffers from chronic kidney disease with an estimated glomerular filtration rate < 45 ml/min/1.73m2.
- Has a history of allergy to iodides or to indocyanine green.
- Suffers from hyperparathyroidism, hypoparathyroidism, or hypocalcaemia prior to surgery.
- Prescription use of supplemental active vitamin D: dihydrotachysterol (ATC 11CC02), alfacalcidol (ATC A11CC03), or calcitriol (ATC A11CC04).
- Patients scheduled to have a radioactive iodine uptake study performed ≤ 7 days after the thyroidectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Total and Completion Thyroidectomy: a Matched Cohort Study
The parathyroid glands and their blood vessels are notoriously difficult to visualize and may therefore be unintentionally and irrevocably damaged during thyroid surgery. This project investigates new surgeon-performed imaging techniques that visualize the parathyroid glands and their vessels in real-time during thyroid surgery. The purpose is to examine, in a matched cohort study, whether the implementation of near-infrared-induced autofluorescence for identification of the parathyroid glands, combined with indocyanine green near-infrared angiography of the parathyroid feeding vessels, can reduce the incidence of postoperative hypocalcaemia in patients undergoing total and completion thyroidectomy at Odense University Hospital.
Read the detailed description
The most common complication after thyroidectomy is postoperative hypoparathyroidism due to unintentional intraoperative injury, excision, or devascularisation of the parathyroid glands. This complication can be either transient (≤6 months), or permanent (> 6 months). The pooled results from four recent studies from three different Danish university hospitals show that 117/945 patients (12.4%) suffered from permanent hypoparathyroidism after total and completion thyroidectomy. This is a very high percentage, considering that the consequences of hypoparathyroidism and its treatment may be severe and include prolonged hospitalization, neuromuscular symptoms, nephrocalcinosis, nephrolithiasis, premature cataracts, seizures, basal ganglia calcification, and increased mortality.
To minimize the risk of postoperative hypoparathyroidism, the standard approach to thyroidectomy is to keep dissection as close to the thyroid capsule as possible while visually scrutinizing the surgical field for the parathyroid glands and their delicate feeding vessels. In spite of these measures, the reported incidences of transient and permanent hypocalcaemia clearly demonstrate a need to further decrease the risk of inadvertent injury to the parathyroid glands and their vessels during thyroid surgery. To achieve this goal, surgeons need a reliable intraoperative aid that can 1) help them identify the parathyroid glands in vivo and 2) locate their feeding vessels and evaluate their perfusion in real-time during thyroid surgery. Recently, two near-infrared fluorescence techniques have emerged, that could potentially meet the requirement of identifying the parathyroid glands and assessing their vasculature using the same piece of technical equipment. The techniques are: near-infrared-induced autofluorescence of the parathyroid glands (NIRAF) for parathyroid identification, and indocyanine green near-infrared angiography (ICGA) for the assessment of parathyroid vascularization. A recent systematic review concluded that these most reported-on optical tools for parathyroid identification and perfusion assessment are favourable for clinical application in terms of being real-time and non-invasive, having a high sensitivity, an excellent safety profile, and involving no exposure to ionizing radiation. Prior to a broader implementation, commercially unaffiliated investigator-initiated studies are needed to evaluate the clinical effect of the bimodal application of NIRAF and ICGA on the incidence of postoperative hypoparathyroidism after total and completion thyroidectomy. This study intends to address this need.
The hypothesis of the study is that near-infrared-induced autofluorescence (NIRAF) combined with indocyanine green near-infrared angiography (ICGA) of the parathyroid glands can reduce the incidence of permanent hypoparathyroidism after total and completion thyroidectomy to 1/3 or less of the incidence in a matched retrospective control group.
- Conditions
- Hypoparathyroidism Postprocedural
- Being tested
- Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography
- Keywords
- Near-infrared fluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared-induced autofluorescence and indocyanine green near-infrared angiographyProcedure or surgery
During thyroid surgery, near-infrared-induced autofluorescence is used for the identification of the parathyroid glands, combined with indocyanine green near-infrared angiography for identification of the parathyroid feeding vessels.
| Study group | Role | What they receive |
|---|---|---|
| NIRAF+ICGA | Experimental | During thyroid surgery, near-infrared-induced autofluorescence is used for the identification of the parathyroid glands, combined with indocyanine green near-infrared angiography for identification of the parathyroid feeding vessels. Receives: Procedure: Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permanent hypoparathyroidism 12 months after surgery
The number of participants in the study cohort with permanent hypoparathyroidism 12 months after treatment compared to the number of participants with permanent hypoparathyroidism 12 months after treatment in a matched retrospective cohort from the same hospital that underwent surgery without NIRAF+ICGA.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Oct 2021
- Primary completion13 Oct 2023
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoparathyroidism PostproceduralStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Matched cohort study
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanne Høxbroe Michaelsen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130476
- Sponsor's protocol ID
- S-20200154
- Status last verified
- Jan 2025
- First submitted
- 8 Nov 2021
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Total and Completion Thyroidectomy: a Matched Cohort Study
- ClinicalTrials.gov ID
- NCT05130476
- Acronym / sponsor ID
- S-20200154
- Conditions
- Hypoparathyroidism Postprocedural
- Keywords
- Near-infrared fluorescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 23 Nov 2021 (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 parathyroid glands and their blood vessels are notoriously difficult to visualize and may therefore be unintentionally and irrevocably damaged during thyroid surgery. This project investigates new surgeon-performed imaging techniques that visualize the parathyroid glands and their vessels in real-time during thyroid surgery. The purpose is to examine, in a matched cohort study, whether the implementation of near-infrared-induced autofluorescence for identification of the parathyroid glands, combined with indocyanine green near-infrared angiography of the parathyroid feeding vessels, can reduce the incidence of postoperative hypocalcaemia in patients undergoing total and completion thyroidectomy at Odense University Hospital.
Detailed description
The most common complication after thyroidectomy is postoperative hypoparathyroidism due to unintentional intraoperative injury, excision, or devascularisation of the parathyroid glands. This complication can be either transient (≤6 months), or permanent (> 6 months). The pooled results from four recent studies from three different Danish university hospitals show that 117/945 patients (12.4%) suffered from permanent hypoparathyroidism after total and completion thyroidectomy. This is a very high percentage, considering that the consequences of hypoparathyroidism and its treatment may be severe and include prolonged hospitalization, neuromuscular symptoms, nephrocalcinosis, nephrolithiasis, premature cataracts, seizures, basal ganglia calcification, and increased mortality.
To minimize the risk of postoperative hypoparathyroidism, the standard approach to thyroidectomy is to keep dissection as close to the thyroid capsule as possible while visually scrutinizing the surgical field for the parathyroid glands and their delicate feeding vessels. In spite of these measures, the reported incidences of transient and permanent hypocalcaemia clearly demonstrate a need to further decrease the risk of inadvertent injury to the parathyroid glands and their vessels during thyroid surgery. To achieve this goal, surgeons need a reliable intraoperative aid that can 1) help them identify the parathyroid glands in vivo and 2) locate their feeding vessels and evaluate their perfusion in real-time during thyroid surgery. Recently, two near-infrared fluorescence techniques have emerged, that could potentially meet the requirement of identifying the parathyroid glands and assessing their vasculature using the same piece of technical equipment. The techniques are: near-infrared-induced autofluorescence of the parathyroid glands (NIRAF) for parathyroid identification, and indocyanine green near-infrared angiography (ICGA) for the assessment of parathyroid vascularization. A recent systematic review concluded that these most reported-on optical tools for parathyroid identification and perfusion assessment are favourable for clinical application in terms of being real-time and non-invasive, having a high sensitivity, an excellent safety profile, and involving no exposure to ionizing radiation. Prior to a broader implementation, commercially unaffiliated investigator-initiated studies are needed to evaluate the clinical effect of the bimodal application of NIRAF and ICGA on the incidence of postoperative hypoparathyroidism after total and completion thyroidectomy. This study intends to address this need.
The hypothesis of the study is that near-infrared-induced autofluorescence (NIRAF) combined with indocyanine green near-infrared angiography (ICGA) of the parathyroid glands can reduce the incidence of permanent hypoparathyroidism after total and completion thyroidectomy to 1/3 or less of the incidence in a matched retrospective control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Matched cohort study
| Arm | Type | Receives |
|---|---|---|
| NIRAF+ICGA | Experimental | Procedure: Near-infrared-induced autofluorescence and indocyanine green near-infrared angiographyDuring thyroid surgery, near-infrared-induced autofluorescence is used for the identification of the parathyroid glands, combined with indocyanine green near-infrared angiography for identification of the parathyroid feeding vessels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years and older who are scheduled to undergo total or completion thyroidectomy at the department of Oro-Rhino-Laryngology (ORL) and Head and Neck Surgery at Odense University Hospital, Denmark.
Key exclusion criteria (8 listed)
- Not legally competent.
- Does not read or speak Danish.
- Is pregnant or nursing.
- Suffers from chronic kidney disease with an estimated glomerular filtration rate < 45 ml/min/1.73m2.
- Has a history of allergy to iodides or to indocyanine green.
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 |
|---|---|---|
| Near-infrared-induced autofluorescence and indocyanine green near-infrared angiographyDuring thyroid surgery, near-infrared-induced autofluorescence is used for the identification of the parathyroid glands, combined with indocyanine green near-infrared angiography for identification of the parathyroid feeding vessels. | Procedure or surgery | NIRAF+ICGA |
Primary outcome
Permanent hypoparathyroidism 12 months after surgery
Time frame: 12 months postoperatively
The number of participants in the study cohort with permanent hypoparathyroidism 12 months after treatment compared to the number of participants with permanent hypoparathyroidism 12 months after treatment in a matched retrospective cohort from the same hospital that underwent surgery without NIRAF+ICGA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography in people with Hypoparathyroidism Postprocedural, run by Odense University Hospital at 1 site 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permanent hypoparathyroidism 12 months after surgery (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2025.