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

Hypocalcemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012476
• Other study ID #: ICG-Parathyroid
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: October 2020

Study information

• Verified date: July 2019
• Source: Hospital Son Espases
• Contact: Jaime Bonnín Pascual, MD
• Phone: 871205959
• Email: jaime.bonnin[@]ssib.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypocalcemia
• Hypoparathyroidism
• Hypoparathyroidism Postprocedural
• Total Thyroidectomy

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Son Espases	Palma De Mallorca	Illes Balears

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Son Espases	Universitat de les Illes Balears

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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 — View Citation

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 Jan 4. pii: S0002-9610(18)31264-9. doi: 10.1016/j.amjsurg.2018.12.074. [Epub ahead of print] — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcemia	Serum calcium level at 24 hours postoperatively	Day 1 after surgery
Primary	Subjective parathyroid fluorescence	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).	Intraoperatively
Primary	Objective parathyroid fluorescence	Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.	Intraoperatively
Secondary	Age	Patient's age	Baseline
Secondary	Sex	Patient's gender	Baseline
Secondary	Body mass index	Patient's BMI	Baseline
Secondary	Surgery date	Day when surgery takes place	Baseline
Secondary	Preoperative diagnosis	Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)	Baseline
Secondary	Vitamin D	Preoperative vitamin D level	Preoperative blood test
Secondary	PTH preop	Preoperative PTH level	Immediately before surgery
Secondary	PTH 10 min	PTH levels 10 minutes post-thyroidectomy	10 minutes post-thyroidectomy
Secondary	Surgery	Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection	Inmediately after surgery
Secondary	Time	Duration of surgery	Inmediately after surgery
Secondary	Parathyroid glands	Number of parathyroid glands located during surgery,	During surgery
Secondary	Parathyroid gland location	Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left).	During surgery
Secondary	Pathologic result	Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis)	during the first month after surgery
Secondary	Thyroid weight	Thyroid weight	during the first month after surgery
Secondary	PG in piece	Presence of parathyroid glands in the surgical piece and number	during the first month after surgery
Secondary	Stay	Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours	During the first month after surgery
Secondary	Drain	Presence and number of surgical drainages	Inmediately after surgery
Secondary	PTH day 1	PTH levels in the postoperative follow-up,	Day 1 after surgery
Secondary	Complications	Emergence of postoperative complications.	During the first month after surgery