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

Primary Purpose

Hypocalcemia, Total Thyroidectomy, Hypoparathyroidism Postprocedural

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
Hospital Son Espases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypocalcemia focused on measuring Hypocalcemia post-thyroidectomy, Indocyanine green, Fluorescence guided surgery, Parathyroid fluorescence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitari Son EspasesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG

Arm Description

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

Outcomes

Primary Outcome Measures

Calcemia
Serum calcium level at 24 hours postoperatively
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).
Objective parathyroid fluorescence
Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.

Secondary Outcome Measures

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

Full Information

First Posted
June 28, 2019
Last Updated
July 7, 2019
Sponsor
Hospital Son Espases
Collaborators
Universitat de les Illes Balears
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1. Study Identification

Unique Protocol Identification Number
NCT04012476
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Son Espases
Collaborators
Universitat de les Illes Balears

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypocalcemia, Total Thyroidectomy, Hypoparathyroidism Postprocedural
Keywords
Hypocalcemia post-thyroidectomy, Indocyanine green, Fluorescence guided surgery, Parathyroid fluorescence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICG
Arm Type
Experimental
Arm Description
Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG
Intervention Description
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Primary Outcome Measure Information:
Title
Calcemia
Description
Serum calcium level at 24 hours postoperatively
Time Frame
Day 1 after surgery
Title
Subjective parathyroid fluorescence
Description
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).
Time Frame
Intraoperatively
Title
Objective parathyroid fluorescence
Description
Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Age
Description
Patient's age
Time Frame
Baseline
Title
Sex
Description
Patient's gender
Time Frame
Baseline
Title
Body mass index
Description
Patient's BMI
Time Frame
Baseline
Title
Surgery date
Description
Day when surgery takes place
Time Frame
Baseline
Title
Preoperative diagnosis
Description
Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)
Time Frame
Baseline
Title
Vitamin D
Description
Preoperative vitamin D level
Time Frame
Preoperative blood test
Title
PTH preop
Description
Preoperative PTH level
Time Frame
Immediately before surgery
Title
PTH 10 min
Description
PTH levels 10 minutes post-thyroidectomy
Time Frame
10 minutes post-thyroidectomy
Title
Surgery
Description
Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection
Time Frame
Inmediately after surgery
Title
Time
Description
Duration of surgery
Time Frame
Inmediately after surgery
Title
Parathyroid glands
Description
Number of parathyroid glands located during surgery,
Time Frame
During surgery
Title
Parathyroid gland location
Description
Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left).
Time Frame
During surgery
Title
Pathologic result
Description
Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis)
Time Frame
during the first month after surgery
Title
Thyroid weight
Description
Thyroid weight
Time Frame
during the first month after surgery
Title
PG in piece
Description
Presence of parathyroid glands in the surgical piece and number
Time Frame
during the first month after surgery
Title
Stay
Description
Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours
Time Frame
During the first month after surgery
Title
Drain
Description
Presence and number of surgical drainages
Time Frame
Inmediately after surgery
Title
PTH day 1
Description
PTH levels in the postoperative follow-up,
Time Frame
Day 1 after surgery
Title
Complications
Description
Emergence of postoperative complications.
Time Frame
During the first month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Bonnín Pascual, MD
Phone
871205959
Email
jaime.bonnin@ssib.es
Facility Information:
Facility Name
Hospital Universitari Son Espases
City
Palma De Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Bonnín Pascual, MD
Phone
871205959
Email
jaime.bonnin@ssib.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26864909
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.
Results Reference
background
PubMed Identifier
29405252
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.
Results Reference
background
PubMed Identifier
27839936
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.
Results Reference
background
PubMed Identifier
27041628
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.
Results Reference
background
PubMed Identifier
30665612
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.
Results Reference
background
PubMed Identifier
30659346
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.
Results Reference
background
PubMed Identifier
30327136
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.
Results Reference
result

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

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