Clinical trial NCT04012476: Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
Official title: Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypocalcemia
Total Thyroidectomy
Hypoparathyroidism Postprocedural
Keywords: Hypocalcemia post-thyroidectomy
Indocyanine green
Fluorescence guided surgery
Parathyroid fluorescence
Lead sponsor: Hospital Son Espases
Sponsor class: OTHER
Collaborators: name: Universitat de les Illes Balears
First posted: 2019-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group: patients undergoing total thyroidectomy with intraoperative infusion of intravenous indocyanine green A prospective unicentric and open clinical trial in which the fluorescence intensity of the parathyroid glands after indocyanine administration will be compared between two groups of patients: those with post-thyroidectomy hypocalcemia and patients who do not present it.
Primary purpose: PREVENTION

Brief summary: The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.

Detailed description: The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:

* To study the correlation between parathyroid vascularization (intraoperative fluorescence intensity) and postoperative glandular function (serum calcium and parathormone levels).
* To compare the surgeon's subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia.
* To compare the objective assessment of parathyroid fluorescence, by using specific computer software developed ad hoc, in the groups of patients with and without postoperative hypocalcemia.

Eligibility criteria: Inclusion Criteria:

* Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection.
* Visualization of 2 or more parathyroid glands during the surgical act.
* Normal renal and hepatic functions.
* Absence of a history of hypersensitivity reactions to iodine or indocyanine green.
* Able to understand the nature and protocol of the study and its procedures
* Willingness to participate with the subsequent signing of informed consent.

Exclusion Criteria:

* Age \<18 years
* Hepatic or renal insufficiency
* Hypersensitivity to iodine or to indocyanine green.
* Pregnancy or lactation
* Inability to understand the nature and procedures of the study.
* Patients with known preoperative hyperparathyroidism.

Primary outcomes:
measure: Calcemia
timeFrame: Day 1 after surgery
measure: Subjective parathyroid fluorescence
timeFrame: Intraoperatively
measure: Objective parathyroid fluorescence
timeFrame: Intraoperatively
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Body mass index
timeFrame: Baseline
measure: Surgery date
timeFrame: Baseline
measure: Preoperative diagnosis
timeFrame: Baseline
measure: Vitamin D
timeFrame: Preoperative blood test
measure: PTH preop
timeFrame: Immediately before surgery
measure: PTH 10 min
timeFrame: 10 minutes post-thyroidectomy
measure: Surgery
timeFrame: Inmediately after surgery
measure: Time
timeFrame: Inmediately after surgery
measure: Parathyroid glands
timeFrame: During surgery
measure: Parathyroid gland location
timeFrame: During surgery
measure: Pathologic result
timeFrame: during the first month after surgery
measure: Thyroid weight
timeFrame: during the first month after surgery
measure: PG in piece
timeFrame: during the first month after surgery
measure: Stay
timeFrame: During the first month after surgery
measure: Drain
timeFrame: Inmediately after surgery
measure: PTH day 1
timeFrame: Day 1 after surgery
measure: Complications
timeFrame: During the first month after surgery
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Illes Balears
Study officials:
References:
citation: 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.
citation: Vidal Fortuny J, Sadowski SM, Belfontali V, Guigard S, Poncet A, Ris F, Karenovics W, Triponez F. Randomized clinical trial of intraoperative parathyroid gland angiography with indocyanine green fluorescence predicting parathyroid function after thyroid surgery. Br J Surg. 2018 Mar;105(4):350-357. doi: 10.1002/bjs.10783. Epub 2018 Feb 6.
citation: Lang BH, Wong CK, Hung HT, Wong KP, Mak KL, Au KB. Indocyanine green fluorescence angiography for quantitative evaluation of in situ parathyroid gland perfusion and function after total thyroidectomy. Surgery. 2017 Jan;161(1):87-95. doi: 10.1016/j.surg.2016.03.037. Epub 2016 Nov 10.
citation: Zaidi N, Bucak E, Yazici P, Soundararajan S, Okoh A, Yigitbas H, Dural C, Berber E. The feasibility of indocyanine green fluorescence imaging for identifying and assessing the perfusion of parathyroid glands during total thyroidectomy. J Surg Oncol. 2016 Jun;113(7):775-8. doi: 10.1002/jso.24237. Epub 2016 Apr 4.
citation: Galvez-Pastor S, Torregrosa NM, Rios A, Febrero B, Gonzalez-Costea R, Garcia-Lopez MA, Balsalobre MD, Pastor-Perez P, Moreno P, Vazquez-Rojas JL, Rodriguez JM. Prediction of hypocalcemia after total thyroidectomy using indocyanine green angiography of parathyroid glands: A simple quantitative scoring system. Am J Surg. 2019 Nov;218(5):993-999. doi: 10.1016/j.amjsurg.2018.12.074. Epub 2019 Jan 4.
citation: Rudin AV, McKenzie TJ, Thompson GB, Farley DR, Lyden ML. Evaluation of Parathyroid Glands with Indocyanine Green Fluorescence Angiography After Thyroidectomy. World J Surg. 2019 Jun;43(6):1538-1543. doi: 10.1007/s00268-019-04909-z.
citation: Bonnin-Pascual J, Alvarez-Segurado C, Jimenez-Segovia M, Bianchi A, Bonnin-Pascual F, Molina-Romero FX, Gonzalez-Argente FX. Contributions of fluorescence to endocrine surgery. Cir Esp (Engl Ed). 2018 Nov;96(9):529-536. doi: 10.1016/j.ciresp.2018.09.005. Epub 2018 Oct 14. English, Spanish.