ThyroidectomyFLUOBNCT04204317
Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy?
An observational study of Thyroidectomy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- 17 Dec 2019to 27 Mar 2020
- Phase
- Observational
- 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
Study population: Our sample size of 180 patients has been calculated after power analysis regarding other similar studies with an a=0.05 and Power=0.95.
Who may be able to join
- Patient is over 18 years old
- Patient scheduled for a non-emergency operation
- Patient eligible for total thyroidectomy
Who cannot join
- Patient is participating in another clinical trial which may affect this study's outcomes
- Prior operation in the neck
- Primary or secondary hyperparathyroidism
- Vitamin D deficiency
- Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy
Read the detailed description
Real-time intraoperative identification and functional maintenance of structures are of major importance in endocrine surgery, with a critical role in clinical outcomes and patients' quality of life. Despite the advances in preoperative imaging techniques, there is still need for precise intraoperative visualizing. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons. Nowadays, attention is attracted to intraoperative imaging techniques using Near Infrared Fluorescence (NIRF) with endogenous or exogenous contrast agents. These imaging techniques are attractive in biomedicine due to its high penetration depth and low scattering in human tissue.
Autofluorescence is the ability of several natural substances or drugs to be fluorescent after the absorbance of light or radiation. It has been already proved that parathyroid glands emit their own light after near-infrared (NIR) around 820nm , providing high contrast to the surrounding tissues. This made near-infrared autofluorescence a potential useful tool in hands of experienced endocrine surgeons in order to distinguish parathyroid glands from other anatomic structures during thyroidectomies.
Approximately 7.6% of thyroid surgeries resulted in hypoparathyroidism, with 75% of these cases being transient and 25% being chronic. The mechanisms that underlie hypoPTH are related to disruption of parathyroid arterial supply or venous drainage, mechanical injury, thermal or electrical injury, and either intentional or inadvertent partial or complete removal.
The aim of the present study is to evaluate the value of intra-operative autofluorescence imaging concerning the unintentional excision rate of parathyroids during total thyroidectomy. Moreover, the investigators are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.
- Conditions
- Thyroidectomy
- Keywords
- autofluorescence, parathyroid glands, thyroidectomy, FLUOBEAM XS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autofluorescence | The surgeon will perform the preplanned operation with FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments 5. Number and location of the visualized glands 6. Intra-operative autofluorescence score (either 0 (no visualization or 1 visualization) for each gland | |
| Control | The surgeon will perform the preplanned operation without FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments |
What is being measured
The primary outcome is the main question the study is designed to answer.
The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy.
The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy
Measured: 6 months
Secondary outcomes (5)
Detecting the changes of practice in performing total thyroidectomy when monitoring parathyroids with autofluorescence.
If autofluorescence is proved to be a useful tool in endocrine surgeons hands, the preservation of parathyroid glands during thyroidectomy would be easier.
Measured: 6 months
Comparing autofluorescence monitored minimal invasive total thyroidectomy with classic minimal invasive total thyroidectomy
To compare the duration and safety of minimal invasive thyroidectomy with or without FLUOBEAM XS
Measured: 6 months
Correlating autofluorescence with 24 hours post-operative PTH.
This study aims to analyze statistically and prove the possible correlation of autofluorescence results with post-operative PTH
Measured: 7 months
Identifying the cut-off points that predict low PTH levels (less than 20pg/ml)
After statistical analysis, we will try to find the cut-off point of PTH levels after autofluorescence results (if they are statistical significant correlated with post-operative PTH)
Measured: 7 months
Identifying and analyzing problematic groups of patients
This study will sign out the disadvantages of FLUOBEAM XS or cases that its use should be avoided.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start17 Dec 2019
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Papavramidis Theodossis, Aristotle University Of Thessaloniki
- Investigators
- Theodossis S Papavramidis, MD, PhD, Principal investigator, AHEPA University Hospital of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204317
- Sponsor's protocol ID
- FLUOB
- Acronym
- FLUOB
- Status last verified
- Apr 2020
- First submitted
- 3 Dec 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy?
- ClinicalTrials.gov ID
- NCT04204317
- Acronym / sponsor ID
- FLUOB / FLUOB
- Conditions
- Thyroidectomy
- Keywords
- autofluorescence, parathyroid glands, thyroidectomy, FLUOBEAM XS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 18 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 aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy
Detailed description
Real-time intraoperative identification and functional maintenance of structures are of major importance in endocrine surgery, with a critical role in clinical outcomes and patients' quality of life. Despite the advances in preoperative imaging techniques, there is still need for precise intraoperative visualizing. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons. Nowadays, attention is attracted to intraoperative imaging techniques using Near Infrared Fluorescence (NIRF) with endogenous or exogenous contrast agents. These imaging techniques are attractive in biomedicine due to its high penetration depth and low scattering in human tissue.
Autofluorescence is the ability of several natural substances or drugs to be fluorescent after the absorbance of light or radiation. It has been already proved that parathyroid glands emit their own light after near-infrared (NIR) around 820nm , providing high contrast to the surrounding tissues. This made near-infrared autofluorescence a potential useful tool in hands of experienced endocrine surgeons in order to distinguish parathyroid glands from other anatomic structures during thyroidectomies.
Approximately 7.6% of thyroid surgeries resulted in hypoparathyroidism, with 75% of these cases being transient and 25% being chronic. The mechanisms that underlie hypoPTH are related to disruption of parathyroid arterial supply or venous drainage, mechanical injury, thermal or electrical injury, and either intentional or inadvertent partial or complete removal.
The aim of the present study is to evaluate the value of intra-operative autofluorescence imaging concerning the unintentional excision rate of parathyroids during total thyroidectomy. Moreover, the investigators are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autofluorescence | – | –The surgeon will perform the preplanned operation with FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments 5. Number and location of the visualized glands 6. Intra-operative autofluorescence score (either 0 (no visualization or 1 visualization) for each gland |
| Control | – | –The surgeon will perform the preplanned operation without FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our sample size of 180 patients has been calculated after power analysis regarding other similar studies with an a=0.05 and Power=0.95.
Key inclusion criteria (3 listed)
- Patient is over 18 years old
- Patient scheduled for a non-emergency operation
- Patient eligible for total thyroidectomy
Key exclusion criteria (5 listed)
- Patient is participating in another clinical trial which may affect this study's outcomes
- Prior operation in the neck
- Primary or secondary hyperparathyroidism
- Vitamin D deficiency
- Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy.
Time frame: 6 months
The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy
5 secondary outcomes
Detecting the changes of practice in performing total thyroidectomy when monitoring parathyroids with autofluorescence.
Time frame: 6 months
Comparing autofluorescence monitored minimal invasive total thyroidectomy with classic minimal invasive total thyroidectomy
Time frame: 6 months
Correlating autofluorescence with 24 hours post-operative PTH.
Time frame: 7 months
Identifying the cut-off points that predict low PTH levels (less than 20pg/ml)
Time frame: 7 months
Identifying and analyzing problematic groups of patients
Time frame: 6 months
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 2 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Theodossis S Papavramidis, MD, PhD principal investigator
AHEPA University Hospital of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroidectomy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 5 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 2 Apr 2020. 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 Greece. 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?
The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy. (time frame: 6 months). 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 2 Apr 2020.