Thyroid DiseasePhase 3NCT05117853
Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy
A Phase 3 study testing Autofluorescent detection + Injection of indocyanine green and Gold standard of visual identification and evaluation of viability of the parathyroid glands. in people with Thyroid Disease and Hypoparathyroidism Postprocedural, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
Trial summary
Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disease, Hypoparathyroidism Postprocedural
- What is being tested?
- Autofluorescent detection + Injection of indocyanine green and Gold standard of visual identification and evaluation of viability of the parathyroid glands.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2021to 31 May 2025
- Phase
- Phase 3
- 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
- All adult patients undergoing a total thyroidectomy without previous neck surgery.
Who cannot join
- Children and teenagers (<18 years old)
- Patients refusing participation or unable/unwilling to sign the informed consent
- Patients with a completion thyroidectomy
- Patients with planned central and lateral neck lymph node dissections (thyroid cancer)
- Patients with previous neck surgery
- Patients with a known allergy/hypersensitivity to indocyanine green
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Onze Lieve Vrouw Hospital
Aalst, 9300
Klaas Van Den Heede, MD, 0032472893861, klaasvandenheede@hormail.com
Sam Van Slycke, MD, PhD, 003253724506, sam.van.slycke@olvz-aalst.be
About this study
Official title: The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial
- Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy.
- The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia.
- Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery.
- Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands.
- This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.
Read the detailed description
Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. When defined as corrected serum calcium levels below 2.10 mmol/L, the temporary rates of hypocalcemia after a total thyroidectomy excluding lymph node neck dissection still easily exceed 20% (BAETS fifth national audit report, 2017). When extending the follow-up period to more than six months after surgery, late or permanent hypocalcemia is seen in over 5% of patients after a total thyroidectomy. These British numbers have been confirmed in large European and American databases. A large, Belgian, single-center analysis, including redo-surgery and lymph node neck dissections, confirmed temporary and permanent rates of hypocalcemia of 32% and 3%, respectively.
While temporary hypocalcemia results in a reduced quality of life, additional medical costs to the patients and the society, and hypocalcemia-related symptoms, permanent hypocalcemia adds an increased risk of developing renal failure, basal ganglia calcifications, neuropsychiatric derangements, and infections.
The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. The visual evaluation of parathyroid gland vascularization is even more challenging, prone to subjectivity, and depending on surgical experience and surgical volume. Moreover, even experienced endocrine surgeons appear to be unreliable in using visual scores to assess the viability of parathyroid glands.
Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. However, this signal does not provide any information on viability and vascularization of the parathyroid glands. Injecting indocyanine green (ICG) and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. The combined technique of autofluorescent and ICG-enhanced imaging suffers from lack of standardization, optimal technique, dosage, and timing of the ICG administration, and still must prove its possible benefit in a clinical setting.
Hence, this randomized clinical trial aims to investigate whether using autofluorescence (AF) and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia. By using parathyroid gland detection via autofluorescence imaging and verifying their viability after ICG injection, the authors aim to identify patients at risk of hypocalcemia.
- Conditions
- Thyroid Disease, Hypoparathyroidism Postprocedural
- Being tested
- Autofluorescent detection + Injection of indocyanine green, Gold standard of visual identification and evaluation of viability of the parathyroid glands.
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autofluorescent detection + Injection of indocyanine greenDrug
Also called ICG Injection
All four parathyroid glands will be actively sought for in every case selected for the use of AF/ICG, with AF verification of parathyroid tissue.
The timepoints of AF will be:
- 1 = after lateral dissection side 1 (side 1)
- 2= after lateral dissection side 2 (side 2)
The timepoints of ICG injection will be:
- 1 = after the first thyroid lobectomy (side 1)
- 2 = after the second thyroid lobectomy (side 2)
Scoring of the viability of parathyroid glands (adapted from Vidal Fortuny et al., 2016):
- 1 = black = not viable/vascularized
- 2 = grey = moderately viably/ moderately vascularized
- 3 = white = viable/well-vascularized
Gold standard of visual identification and evaluation of viability of the parathyroid glands.Procedure or surgery
Gold standard of visual identification and evaluation of viability of the parathyroid glands.
| Study group | Role | What they receive |
|---|---|---|
| Autofluorescent detection and injection of indocyanine green | Experimental | Drug: indocyanine green (ICG)
Autofluorescence detection of the parathyroid glands and injection of indocyanine green at two predefined timepoints will be performed to evaluate the vascularization of the parathyroid glands. Receives: Drug: Autofluorescent detection + Injection of indocyanine green |
| Control group | Placebo comparator | Gold standard of visual identification and evaluation of viability. Receives: Procedure: Gold standard of visual identification and evaluation of viability of the parathyroid glands. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hypocalcemia
Defined as parathyroid hormone (PTH) levels <15 pg/mL, serum calcium levels <2.10 mmol/L, or the intake of calcium or activated vitamin D supplements after total thyroidectomy.
Measured: One week after surgery
Secondary outcomes (3)
The number of identified parathyroid glands
Visual identification and confirmation with autofluorescence
Measured: 1 hour after surgery
The number of reimplanted parathyroid glands
Visual identification and decision to re-implant after ICG
Measured: 1 hour after surgery
The presence of late or permanent hypocalcemia
Defined as persistent PTH levels <15 pg/mL, persistent serum calcium levels <2.10 mmol/L, or continued intake of calcium or activated vitamin D supplements more than six months after surgery.
Measured: Six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Nov 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, comparative, randomized, single-blind, controlled trial against the gold standard of visual identification and viability evaluation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaas Van Den Heede, Onze Lieve Vrouw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117853
- Sponsor's protocol ID
- B1262021000021
- Status last verified
- Apr 2024
- First submitted
- 21 Oct 2021
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Publications
Sitges-Serra A. Etiology and Diagnosis of Permanent Hypoparathyroidism after Total Thyroidectomy. J Clin Med. 2021 Feb 2;10(3):543. doi: 10.3390/jcm10030543.
PubMed 33540657Moten AS, Thibault DP, Willis AW, Willis AI. Demographics, disparities, and outcomes in substernal goiters in the United States. Am J Surg. 2016 Apr;211(4):703-9. doi: 10.1016/j.amjsurg.2015.11.022. Epub 2016 Jan 6.
PubMed 26813846Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
PubMed 24402815Lorente-Poch L, Sancho JJ, Munoz-Nova JL, Sanchez-Velazquez P, Sitges-Serra A. Defining the syndromes of parathyroid failure after total thyroidectomy. Gland Surg. 2015 Feb;4(1):82-90. doi: 10.3978/j.issn.2227-684X.2014.12.04.
PubMed 25713783Van Slycke S, Van Den Heede K, Bruggeman N, Vermeersch H, Brusselaers N. Risk factors for postoperative morbidity after thyroid surgery in a PROSPECTIVE cohort of 1500 patients. Int J Surg. 2021 Apr;88:105922. doi: 10.1016/j.ijsu.2021.105922. Epub 2021 Mar 25.
PubMed 33774174Van Den Heede K, Tolley NS, Di Marco AN, Palazzo FF. Differentiated Thyroid Cancer: A Health Economic Review. Cancers (Basel). 2021 May 7;13(9):2253. doi: 10.3390/cancers13092253.
PubMed 34067214Eismontas V, Slepavicius A, Janusonis V, Zeromskas P, Beisa V, Strupas K, Dambrauskas Z, Gulbinas A, Martinkenas A. Predictors of postoperative hypocalcemia occurring after a total thyroidectomy: results of prospective multicenter study. BMC Surg. 2018 Aug 9;18(1):55. doi: 10.1186/s12893-018-0387-2.
PubMed 30092793Ji YB, Song CM, Sung ES, Jeong JH, Lee CB, Tae K. Postoperative Hypoparathyroidism and the Viability of the Parathyroid Glands During Thyroidectomy. Clin Exp Otorhinolaryngol. 2017 Sep;10(3):265-271. doi: 10.21053/ceo.2016.00724. Epub 2016 Aug 13.
PubMed 27515510Van Slycke S, Van Den Heede K, Brusselaers N, Vermeersch H. Feasibility of Autofluorescence for Parathyroid Glands During Thyroid Surgery and the Risk of Hypocalcemia: First Results in Belgium and Review of the Literature. Surg Innov. 2021 Aug;28(4):409-418. doi: 10.1177/1553350620980263. Epub 2020 Dec 29.
PubMed 33372584Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chereau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613.
PubMed 31693081Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741.
PubMed 31882459Riley RD, Moons KGM, Snell KIE, Ensor J, Hooft L, Altman DG, Hayden J, Collins GS, Debray TPA. A guide to systematic review and meta-analysis of prognostic factor studies. BMJ. 2019 Jan 30;364:k4597. doi: 10.1136/bmj.k4597. No abstract available.
PubMed 30700442Alander JT, Kaartinen I, Laakso A, Patila T, Spillmann T, Tuchin VV, Venermo M, Valisuo P. A review of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:940585. doi: 10.1155/2012/940585. Epub 2012 Apr 22.
PubMed 22577366Reinhart MB, Huntington CR, Blair LJ, Heniford BT, Augenstein VA. Indocyanine Green: Historical Context, Current Applications, and Future Considerations. Surg Innov. 2016 Apr;23(2):166-75. doi: 10.1177/1553350615604053. Epub 2015 Sep 10.
PubMed 26359355Obana A, Miki T, Hayashi K, Takeda M, Kawamura A, Mutoh T, Harino S, Fukushima I, Komatsu H, Takaku Y, et al. Survey of complications of indocyanine green angiography in Japan. Am J Ophthalmol. 1994 Dec 15;118(6):749-53. doi: 10.1016/s0002-9394(14)72554-1.
PubMed 7977601
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05117853
- Acronym / sponsor ID
- B1262021000021
- Conditions
- Thyroid Disease, Hypoparathyroidism Postprocedural
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 11 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.
- Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy.
- The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia.
- Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery.
- Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands.
- This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.
Detailed description
Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. When defined as corrected serum calcium levels below 2.10 mmol/L, the temporary rates of hypocalcemia after a total thyroidectomy excluding lymph node neck dissection still easily exceed 20% (BAETS fifth national audit report, 2017). When extending the follow-up period to more than six months after surgery, late or permanent hypocalcemia is seen in over 5% of patients after a total thyroidectomy. These British numbers have been confirmed in large European and American databases. A large, Belgian, single-center analysis, including redo-surgery and lymph node neck dissections, confirmed temporary and permanent rates of hypocalcemia of 32% and 3%, respectively.
While temporary hypocalcemia results in a reduced quality of life, additional medical costs to the patients and the society, and hypocalcemia-related symptoms, permanent hypocalcemia adds an increased risk of developing renal failure, basal ganglia calcifications, neuropsychiatric derangements, and infections.
The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. The visual evaluation of parathyroid gland vascularization is even more challenging, prone to subjectivity, and depending on surgical experience and surgical volume. Moreover, even experienced endocrine surgeons appear to be unreliable in using visual scores to assess the viability of parathyroid glands.
Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. However, this signal does not provide any information on viability and vascularization of the parathyroid glands. Injecting indocyanine green (ICG) and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. The combined technique of autofluorescent and ICG-enhanced imaging suffers from lack of standardization, optimal technique, dosage, and timing of the ICG administration, and still must prove its possible benefit in a clinical setting.
Hence, this randomized clinical trial aims to investigate whether using autofluorescence (AF) and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia. By using parathyroid gland detection via autofluorescence imaging and verifying their viability after ICG injection, the authors aim to identify patients at risk of hypocalcemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-center, comparative, randomized, single-blind, controlled trial against the gold standard of visual identification and viability evaluation.
| Arm | Type | Receives |
|---|---|---|
| Autofluorescent detection and injection of indocyanine green | Experimental | Drug: Autofluorescent detection + Injection of indocyanine greenDrug: indocyanine green (ICG) Autofluorescence detection of the parathyroid glands and injection of indocyanine green at two predefined timepoints will be performed to evaluate the vascularization of the parathyroid glands. |
| Control group | Placebo comparator | Procedure: Gold standard of visual identification and evaluation of viability of the parathyroid glands.Gold standard of visual identification and evaluation of viability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients undergoing a total thyroidectomy without previous neck surgery.
Key exclusion criteria (6 listed)
- Children and teenagers (<18 years old)
- Patients refusing participation or unable/unwilling to sign the informed consent
- Patients with a completion thyroidectomy
- Patients with planned central and lateral neck lymph node dissections (thyroid cancer)
- Patients with previous neck surgery
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 |
|---|---|---|
| Autofluorescent detection + Injection of indocyanine greenAlso: ICG InjectionAll four parathyroid glands will be actively sought for in every case selected for the use of AF/ICG, with AF verification of parathyroid tissue. The timepoints of AF will be: * 1 = after lateral dissection side 1 (side 1) * 2= after lateral dissection side 2 (side 2) The timepoints of ICG injection will be: * 1 = after the first thyroid lobectomy (side 1) * 2 = after the second thyroid lobectomy (side 2) Scoring of the viability of parathyroid glands (adapted from Vidal Fortuny et al., 2016): * 1 = black = not viable/vascularized * 2 = grey = moderately viably/ moderately vascularized * 3 = white = viable/well-vascularized | Drug | Autofluorescent detection and injection of indocyanine green |
| Gold standard of visual identification and evaluation of viability of the parathyroid glands.Gold standard of visual identification and evaluation of viability of the parathyroid glands. | Procedure or surgery | Control group |
Primary outcome
Postoperative hypocalcemia
Time frame: One week after surgery
Defined as parathyroid hormone (PTH) levels <15 pg/mL, serum calcium levels <2.10 mmol/L, or the intake of calcium or activated vitamin D supplements after total thyroidectomy.
3 secondary outcomes
The number of identified parathyroid glands
Time frame: 1 hour after surgery
The number of reimplanted parathyroid glands
Time frame: 1 hour after surgery
The presence of late or permanent hypocalcemia
Time frame: Six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 33540657Sitges-Serra A. Etiology and Diagnosis of Permanent Hypoparathyroidism after Total Thyroidectomy. J Clin Med. 2021 Feb 2;10(3):543. doi: 10.3390/jcm10030543.
- Background: PubMed 26813846Moten AS, Thibault DP, Willis AW, Willis AI. Demographics, disparities, and outcomes in substernal goiters in the United States. Am J Surg. 2016 Apr;211(4):703-9. doi: 10.1016/j.amjsurg.2015.11.022. Epub 2016 Jan 6.
- Background: PubMed 24402815Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
- Background: PubMed 25713783Lorente-Poch L, Sancho JJ, Munoz-Nova JL, Sanchez-Velazquez P, Sitges-Serra A. Defining the syndromes of parathyroid failure after total thyroidectomy. Gland Surg. 2015 Feb;4(1):82-90. doi: 10.3978/j.issn.2227-684X.2014.12.04.
- Background: PubMed 33774174Van Slycke S, Van Den Heede K, Bruggeman N, Vermeersch H, Brusselaers N. Risk factors for postoperative morbidity after thyroid surgery in a PROSPECTIVE cohort of 1500 patients. Int J Surg. 2021 Apr;88:105922. doi: 10.1016/j.ijsu.2021.105922. Epub 2021 Mar 25.
- Background: PubMed 34067214Van Den Heede K, Tolley NS, Di Marco AN, Palazzo FF. Differentiated Thyroid Cancer: A Health Economic Review. Cancers (Basel). 2021 May 7;13(9):2253. doi: 10.3390/cancers13092253.
- Background: PubMed 30092793Eismontas V, Slepavicius A, Janusonis V, Zeromskas P, Beisa V, Strupas K, Dambrauskas Z, Gulbinas A, Martinkenas A. Predictors of postoperative hypocalcemia occurring after a total thyroidectomy: results of prospective multicenter study. BMC Surg. 2018 Aug 9;18(1):55. doi: 10.1186/s12893-018-0387-2.
- Background: PubMed 27515510Ji YB, Song CM, Sung ES, Jeong JH, Lee CB, Tae K. Postoperative Hypoparathyroidism and the Viability of the Parathyroid Glands During Thyroidectomy. Clin Exp Otorhinolaryngol. 2017 Sep;10(3):265-271. doi: 10.21053/ceo.2016.00724. Epub 2016 Aug 13.
- Background: PubMed 33372584Van Slycke S, Van Den Heede K, Brusselaers N, Vermeersch H. Feasibility of Autofluorescence for Parathyroid Glands During Thyroid Surgery and the Risk of Hypocalcemia: First Results in Belgium and Review of the Literature. Surg Innov. 2021 Aug;28(4):409-418. doi: 10.1177/1553350620980263. Epub 2020 Dec 29.
- Background: PubMed 31693081Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chereau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613.
- Background: PubMed 31882459Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741.
- Background: PubMed 30700442Riley RD, Moons KGM, Snell KIE, Ensor J, Hooft L, Altman DG, Hayden J, Collins GS, Debray TPA. A guide to systematic review and meta-analysis of prognostic factor studies. BMJ. 2019 Jan 30;364:k4597. doi: 10.1136/bmj.k4597. No abstract available.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autofluorescent detection + Injection of indocyanine green and Gold standard of visual identification and evaluation of viability of the parathyroid glands. in people with Thyroid Disease and Hypoparathyroidism Postprocedural, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
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 6 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 5 Apr 2024. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Klaas Van Den Heede, MD (0032472893861, klaasvandenheede@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hypocalcemia (time frame: One week after surgery). 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 NCT05117853, which also lists 22 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 5 Apr 2024.