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出境医 / 临床实验 / Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy

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

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.

Condition or disease Intervention/treatment Phase
Hypocalcemia Total Thyroidectomy Hypoparathyroidism Postprocedural Drug: Indocyanine Green Phase 4

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
Actual Study Start Date : November 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020
Arms and Interventions
Arm Intervention/treatment
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
 Drug: Indocyanine Green
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Other Name: ICG
Outcome Measures
Primary Outcome Measures :
  1. Calcemia [ Time Frame: Day 1 after surgery ]
    Serum calcium level at 24 hours postoperatively

  2. 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).

  3. 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 Outcome Measures :
  1. Age [ Time Frame: Baseline ]
    Patient's age

  2. Sex [ Time Frame: Baseline ]
    Patient's gender

  3. Body mass index [ Time Frame: Baseline ]
    Patient's BMI

  4. Surgery date [ Time Frame: Baseline ]
    Day when surgery takes place

  5. Preoperative diagnosis [ Time Frame: Baseline ]
    Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)

  6. Vitamin D [ Time Frame: Preoperative blood test ]
    Preoperative vitamin D level

  7. PTH preop [ Time Frame: Immediately before surgery ]
    Preoperative PTH level

  8. PTH 10 min [ Time Frame: 10 minutes post-thyroidectomy ]
    PTH levels 10 minutes post-thyroidectomy

  9. Surgery [ Time Frame: Inmediately after surgery ]
    Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection

  10. Time [ Time Frame: Inmediately after surgery ]
    Duration of surgery

  11. Parathyroid glands [ Time Frame: During surgery ]
    Number of parathyroid glands located during surgery,

  12. Parathyroid gland location [ Time Frame: During surgery ]
    Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left).

  13. Pathologic result [ Time Frame: during the first month after surgery ]
    Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis)

  14. Thyroid weight [ Time Frame: during the first month after surgery ]
    Thyroid weight

  15. PG in piece [ Time Frame: during the first month after surgery ]
    Presence of parathyroid glands in the surgical piece and number

  16. 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

  17. Drain [ Time Frame: Inmediately after surgery ]
    Presence and number of surgical drainages

  18. PTH day 1 [ Time Frame: Day 1 after surgery ]
    PTH levels in the postoperative follow-up,

  19. Complications [ Time Frame: During the first month after surgery ]
    Emergence of postoperative complications.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jaime Bonnín Pascual, MD 871205959 jaime.bonnin@ssib.es

Locations
Layout table for location information
Spain
Hospital Universitari Son Espases Recruiting
Palma De Mallorca, Illes Balears, Spain, 07120
Contact: Jaime Bonnín Pascual, MD    871205959    jaime.bonnin@ssib.es   
Sponsors and Collaborators
Hospital Son Espases
Universitat de les Illes Balears
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE November 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
Official Title  ICMJE Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hypocalcemia
  • Total Thyroidectomy
  • Hypoparathyroidism Postprocedural
Intervention  ICMJE Drug: Indocyanine Green
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Other Name: ICG
Study Arms  ICMJE 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
Intervention: Drug: Indocyanine Green
Publications *
  • 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.
  • 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 (Engl Ed). 2018 Nov;96(9):529-536. doi: 10.1016/j.ciresp.2018.09.005. Epub 2018 Oct 14. English, Spanish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jaime Bonnín Pascual, MD 871205959 jaime.bonnin@ssib.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012476
Other Study ID Numbers  ICMJE ICG-Parathyroid
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospital Son Espases
Study Sponsor  ICMJE Hospital Son Espases
Collaborators  ICMJE Universitat de les Illes Balears
Investigators  ICMJE Not Provided
PRS Account Hospital Son Espases
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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