NCT04012476

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

3.3 years

First QC Date

June 28, 2019

Last Update Submit

July 7, 2019

Conditions

HypocalcemiaTotal ThyroidectomyHypoparathyroidism Postprocedural

Keywords

Hypocalcemia post-thyroidectomyIndocyanine greenFluorescence guided surgeryParathyroid fluorescence

Outcome Measures

Primary Outcomes (3)

  • Calcemia

    Serum calcium level at 24 hours postoperatively

    Day 1 after surgery

  • 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

  • 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 Outcomes (19)

  • Age

    Baseline

  • Sex

    Baseline

  • Body mass index

    Baseline

  • Surgery date

    Baseline

  • Preoperative diagnosis

    Baseline

  • +14 more secondary outcomes

Study Arms (1)

ICG

EXPERIMENTAL

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

Interventions

Indocyanine GreenDRUG

Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light

Also known as: ICG
ICG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

Related Publications (7)

  • 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.

    PMID: 26864909BACKGROUND

  • 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.

    PMID: 29405252BACKGROUND

  • 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.

    PMID: 27839936BACKGROUND

  • 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.

    PMID: 27041628BACKGROUND

  • 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.

    PMID: 30665612BACKGROUND

  • 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.

    PMID: 30659346BACKGROUND

  • 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.

    PMID: 30327136RESULT

MeSH Terms

Conditions

Hypocalcemia

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Jaime BonnĂ­n Pascual, MD

CONTACT

871205959jaime.bonnin@ssib.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 9, 2019

Study Start

November 1, 2016

Primary Completion

March 1, 2020

Study Completion

October 1, 2020

Last Updated

July 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)