Hypoparathyroidism PostproceduralNCT04509011
Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery
A study testing Fluobeam® LX in people with Hypoparathyroidism Postprocedural, run by Region Skane at 5 sites in 4 countries.
Trial summary
The purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low PTH in patients undergoing total thyroidectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism Postprocedural
- What is being tested?
- Fluobeam® LX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 5 Jan 2021to 31 Jul 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
- Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis
Who cannot join
- Previous thyroid surgery
- Previous parathyroid surgery
- Concurrent parathyroid surgery
- Renal insufficiency
- Pregnancy
- Breast feeding
Show all 9Show fewer
- Allergy (contrast agent, iodine)
- Inability to understand study information
- Patient unable to participate in planned follow-up program
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, 41345
Skåne University Hospital, Department of Surgery, Lund
Lund, 22185
About this study
Official title: Randomized Controlled Trial of Fluobeam® LX Compared With Clinical Assessment of Parathyroid Glands to Counteract Postoperatively Failing Parathyroid Function With Low Blood Calcium After Thyroid Surgery
The purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low PTH in patients undergoing total thyroidectomy
Read the detailed description
Temporary and permanent hypoparathyroidism is probably the most important complication of total thyroidectomy. The rate of permanent hypoparathyroidism in quality registries are in the range of is 5-7 percent of patients undergoing surgery.
Patients operated on benign disease with total thyroidectomy, and who suffer from permanent hypoparathyroidism (defined as medication with active Vitamin D analogue therapy for more than 6 months, are at increased risk of renal insufficiency. They also have, for unclear reasons, an increased risk of suffering from malignancy, compared to patients without this complication. Patients with known ischemic heart disease before surgery also have an increased risk of suffering a new episode of cardiovascular disease. Finally, patients with permanent hypoparathyroidism have an increased risk of mortality compared to patients without this complication.
If, by using a technique for autofluorescence (Fluobeam® -LX), one can more accurately identify and avoid damage to the parathyroid glands during the surgical procedure, this would be of great importance for patients undergoing total thyroidectomy for thyroid disease.
Patients undergoing total thyroidectomy are randomized to the use of Fluobeam® -LX to detect the parathyroid glands through autofluorescence during thyroid surgery, or clinical evaluation only (control). Outcome is evaluated by parathyroid hormon (PTH) levels the first postoperative day and the need for medication with calcium and Vitamin D up to 6 months postoperatively.
- Conditions
- Hypoparathyroidism Postprocedural
- Being tested
- Fluobeam® LX
- Keywords
- Hypoparathyroidism, PTH, Hypocalcemia
- Medical subject headings
- Hypoparathyroidism, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluobeam® LXDevice
Fluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery.
| Study group | Role | What they receive |
|---|---|---|
| Fluobeam® LX | Experimental | Fluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands Receives: Device: Fluobeam® LX |
| Control | No intervention | In the control group, the parathyroid glands are identified and evaluated by eye (ocular examination). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative level of Parathyroid hormone (PTH)
Low plasma parathyroid hormone (PTH) (below the normal reference range)
Measured: First postoperative day
Secondary outcomes (8)
Postoperative medication with Active vitamin D
Medication with active Vitamin D; dihydrotachysterol (ATC A11CC02), alfacalcidol (ATC A11CC03), or calcitriol (ATC A11CC04) due to postoperative hypocalcaemia. Evaluated by standard questionaire in the database "Eurocrine" (yes/no)
Measured: At discharge (up to 7 days), at 1 month and at 6 months
Postoperative medication with oral calcium
Medication with oral calcium; calcium carbonate (A12AA04), and calcium lactate gluconate (A12AA06) Evaluated by standard questionaire in the database "Eurocrine" (yes/no)
Measured: At discharge (up to 7 days), at 1 month and at 6 months
Identification of parathyroid glands
Number of identified parathyroid glands
Measured: Intraoperatively
Autotransplantation of parathyroid tissue
Number of autotransplanted parathyroid glands
Measured: Intraoperatively
Excised parathyroid glands
Number of excised parathyroid glands found on the specimen at histopathology
Measured: One week
Time for operation
Time for surgery (skin to skin) in minutes
Measured: Intraoperatively
Hospital stay
Hospital stay in days
Measured: One week
Re-hospitalization due to hypocalcaemia
Any subsequent hospitalization within 30 days for hypocalcaemia-related symptoms
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start5 Jan 2021
- Primary completion1 Oct 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Region SkaneThe 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
- Model description
- Intervention group (intraoperative use of Fluobeam®-LX during thyroid surgery) Control group (clinical assessment and identification of parathyroid glands during thyroid surgery)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Jagiellonian University, Sahlgrenska University Hospital, Hospital Rudolfstiftung
- Responsible party
- Sponsor
- Investigators
- Anders OJ Bergenfelz, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509011
- Sponsor's protocol ID
- 2019-05948
- Other IDs
- 2019
- Status last verified
- Nov 2024
- First submitted
- 4 Aug 2020
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in a publication. Individuals are de-identified
Publications
Bergenfelz A, Barczynski M, Heie A, Muth A, Passler C, Schneider M, Wierzbicka P, Konturek A, Brauckhoff K, Elf AK, Dahlberg J, Hermann M. Impact of autofluorescence for detection of parathyroid glands during thyroidectomy on postoperative parathyroid hormone levels: parallel multicentre randomized clinical trial. Br J Surg. 2023 Nov 9;110(12):1824-1833. doi: 10.1093/bjs/znad278.
PubMed 37758507
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Fluobeam® LX Compared With Clinical Assessment of Parathyroid Glands to Counteract Postoperatively Failing Parathyroid Function With Low Blood Calcium After Thyroid Surgery
- ClinicalTrials.gov ID
- NCT04509011
- Acronym / sponsor ID
- 2019-05948
- Conditions
- Hypoparathyroidism Postprocedural
- Keywords
- Hypoparathyroidism, PTH, Hypocalcemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Jagiellonian University, Sahlgrenska University Hospital, Hospital Rudolfstiftung
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 11 Aug 2020 (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 purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low PTH in patients undergoing total thyroidectomy
Detailed description
Temporary and permanent hypoparathyroidism is probably the most important complication of total thyroidectomy. The rate of permanent hypoparathyroidism in quality registries are in the range of is 5-7 percent of patients undergoing surgery.
Patients operated on benign disease with total thyroidectomy, and who suffer from permanent hypoparathyroidism (defined as medication with active Vitamin D analogue therapy for more than 6 months, are at increased risk of renal insufficiency. They also have, for unclear reasons, an increased risk of suffering from malignancy, compared to patients without this complication. Patients with known ischemic heart disease before surgery also have an increased risk of suffering a new episode of cardiovascular disease. Finally, patients with permanent hypoparathyroidism have an increased risk of mortality compared to patients without this complication.
If, by using a technique for autofluorescence (Fluobeam® -LX), one can more accurately identify and avoid damage to the parathyroid glands during the surgical procedure, this would be of great importance for patients undergoing total thyroidectomy for thyroid disease.
Patients undergoing total thyroidectomy are randomized to the use of Fluobeam® -LX to detect the parathyroid glands through autofluorescence during thyroid surgery, or clinical evaluation only (control). Outcome is evaluated by parathyroid hormon (PTH) levels the first postoperative day and the need for medication with calcium and Vitamin D up to 6 months postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention group (intraoperative use of Fluobeam®-LX during thyroid surgery) Control group (clinical assessment and identification of parathyroid glands during thyroid surgery)
| Arm | Type | Receives |
|---|---|---|
| Fluobeam® LX | Experimental | Device: Fluobeam® LXFluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands |
| Control | No intervention | –In the control group, the parathyroid glands are identified and evaluated by eye (ocular examination). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis
Key exclusion criteria (9 listed)
- Previous thyroid surgery
- Previous parathyroid surgery
- Concurrent parathyroid surgery
- Renal insufficiency
- Pregnancy
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 |
|---|---|---|
| Fluobeam® LXFluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery. | Device | Fluobeam® LX |
Primary outcome
Postoperative level of Parathyroid hormone (PTH)
Time frame: First postoperative day
Low plasma parathyroid hormone (PTH) (below the normal reference range)
8 secondary outcomes
Postoperative medication with Active vitamin D
Time frame: At discharge (up to 7 days), at 1 month and at 6 months
Postoperative medication with oral calcium
Time frame: At discharge (up to 7 days), at 1 month and at 6 months
Identification of parathyroid glands
Time frame: Intraoperatively
Autotransplantation of parathyroid tissue
Time frame: Intraoperatively
Excised parathyroid glands
Time frame: One week
Time for operation
Time frame: Intraoperatively
Hospital stay
Time frame: One week
Re-hospitalization due to hypocalcaemia
Time frame: One month
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 15 Nov 2024.
- Derived from this study: PubMed 37758507Bergenfelz A, Barczynski M, Heie A, Muth A, Passler C, Schneider M, Wierzbicka P, Konturek A, Brauckhoff K, Elf AK, Dahlberg J, Hermann M. Impact of autofluorescence for detection of parathyroid glands during thyroidectomy on postoperative parathyroid hormone levels: parallel multicentre randomized clinical trial. Br J Surg. 2023 Nov 9;110(12):1824-1833. doi: 10.1093/bjs/znad278.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication. Individuals are de-identified
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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.
Anders OJ Bergenfelz, PhD principal investigator
Skane University Hospital
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluobeam® LX in people with Hypoparathyroidism Postprocedural, run by Region Skane at 5 sites in 4 countries.
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 9 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 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Austria, Norway, Poland. 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?
Postoperative level of Parathyroid hormone (PTH) (time frame: First postoperative day). 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 NCT04509011, which also lists 1 linked publication.
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 15 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.