Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2020

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.

Interventions

  • Drug: Indocyanine Green
    • Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light

Arms, Groups and Cohorts

  • Experimental: ICG
    • Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green

Clinical Trial Outcome Measures

Primary Measures

  • Calcemia
    • Time Frame: Day 1 after surgery
    • Serum calcium level at 24 hours postoperatively
  • Subjective parathyroid fluorescence
    • Time Frame: Intraoperatively
    • Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured on a subjective analogue scale (0: no fluorescence, 1: hypofluorescence or heterogeneous fluorescence, 2: homogeneous hyperfluorescence).
  • Objective parathyroid fluorescence
    • Time Frame: Intraoperatively
    • Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.

Secondary Measures

  • Age
    • Time Frame: Baseline
    • Patient’s age
  • Sex
    • Time Frame: Baseline
    • Patient’s gender
  • Body mass index
    • Time Frame: Baseline
    • Patient’s BMI
  • Surgery date
    • Time Frame: Baseline
    • Day when surgery takes place
  • Preoperative diagnosis
    • Time Frame: Baseline
    • Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)
  • Vitamin D
    • Time Frame: Preoperative blood test
    • Preoperative vitamin D level
  • PTH preop
    • Time Frame: Immediately before surgery
    • Preoperative PTH level
  • PTH 10 min
    • Time Frame: 10 minutes post-thyroidectomy
    • PTH levels 10 minutes post-thyroidectomy
  • Surgery
    • Time Frame: Inmediately after surgery
    • Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection
  • Time
    • Time Frame: Inmediately after surgery
    • Duration of surgery
  • Parathyroid glands
    • Time Frame: During surgery
    • Number of parathyroid glands located during surgery,
  • Parathyroid gland location
    • Time Frame: During surgery
    • Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left).
  • Pathologic result
    • Time Frame: during the first month after surgery
    • Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis)
  • Thyroid weight
    • Time Frame: during the first month after surgery
    • Thyroid weight
  • PG in piece
    • Time Frame: during the first month after surgery
    • Presence of parathyroid glands in the surgical piece and number
  • Stay
    • Time Frame: During the first month after surgery
    • Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours
  • Drain
    • Time Frame: Inmediately after surgery
    • Presence and number of surgical drainages
  • PTH day 1
    • Time Frame: Day 1 after surgery
    • PTH levels in the postoperative follow-up,
  • Complications
    • Time Frame: During the first month after surgery
    • Emergence of postoperative complications.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Son Espases
  • Collaborator
    • Universitat de les Illes Balears
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jaime Bonnín Pascual, MD, 871205959, jaime.bonnin@ssib.es

References

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.

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.

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.

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.

Gálvez-Pastor S, Torregrosa NM, Ríos A, Febrero B, González-Costea R, García-López MA, Balsalobre MD, Pastor-Pérez P, Moreno P, Vázquez-Rojas JL, Rodríguez 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.

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.

Citations Reporting on Results

Bonnin-Pascual J, Álvarez-Segurado C, Jiménez-Segovia M, Bianchi A, Bonnin-Pascual F, Molina-Romero FX, González-Argente FX. Contributions of fluorescence to endocrine surgery. Cir Esp. 2018 Nov;96(9):529-536. doi: 10.1016/j.ciresp.2018.09.005. Epub 2018 Oct 14. English, Spanish.

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