Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy
NCT ID: NCT05117853
Last Updated: 2024-04-05
Study Results
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Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2021-11-01
2025-05-31
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Autofluorescent detection and injection of indocyanine green
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.
Autofluorescent detection + Injection of indocyanine green
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
Control group
Gold standard of visual identification and evaluation of viability.
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.
Interventions
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Autofluorescent detection + Injection of indocyanine green
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.
Gold standard of visual identification and evaluation of viability of the parathyroid glands.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Onze Lieve Vrouw Hospital
OTHER
Responsible Party
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Klaas Van Den Heede
Principal Investigator / Scientific Fellow
Locations
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Onze Lieve Vrouw Hospital
Aalst, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Moten 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.
Edafe 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.
Lorente-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.
Van 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.
Van 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.
Eismontas 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.
Ji 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.
Van 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.
Benmiloud 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.
Spartalis 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.
Riley 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.
Alander 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.
Reinhart 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.
Obana 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.
Desmettre T, Devoisselle JM, Mordon S. Fluorescence properties and metabolic features of indocyanine green (ICG) as related to angiography. Surv Ophthalmol. 2000 Jul-Aug;45(1):15-27. doi: 10.1016/s0039-6257(00)00123-5.
Vidal Fortuny J, Belfontali V, Sadowski SM, Karenovics W, Guigard S, Triponez F. Parathyroid gland angiography with indocyanine green fluorescence to predict parathyroid function after thyroid surgery. Br J Surg. 2016 Apr;103(5):537-43. doi: 10.1002/bjs.10101. Epub 2016 Feb 11.
Mirallie E, Borel F, Tresallet C, Hamy A, Mathonnet M, Lifante JC, Brunaud L, Menegaux F, Hardouin JB, Blanchard C; THYRQOL Group; Ansquer C, Mourrain-Langlois E, Delemazure AS, Perrot B, Longhi M, Nomine C, Espitalier F, Drui D, Caillard C, Renaud-Moreau N, Marret O, Mucci S, Christou N. Impact of total thyroidectomy on quality of life at 6 months: the prospective ThyrQoL multicentre trial. Eur J Endocrinol. 2020 Feb;182(2):195-205. doi: 10.1530/EJE-19-0587.
Watt T, Cramon P, Hegedus L, Bjorner JB, Bonnema SJ, Rasmussen AK, Feldt-Rasmussen U, Groenvold M. The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects. J Clin Endocrinol Metab. 2014 Oct;99(10):3708-17. doi: 10.1210/jc.2014-1322. Epub 2014 Jul 8.
Chen Z, Zhao Q, Du J, Wang Y, Han R, Xu C, Chen X, Shu M. Risk factors for postoperative hypocalcaemia after thyroidectomy: A systematic review and meta-analysis. J Int Med Res. 2021 Mar;49(3):300060521996911. doi: 10.1177/0300060521996911.
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Other Identifiers
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B1262021000021
Identifier Type: -
Identifier Source: org_study_id
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