This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography (ANGIO_PARA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05328076
Recruitment Status : Active, not recruiting
First Posted : April 14, 2022
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Riccardo Maggiore, IRCCS San Raffaele

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy.

The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism.

It is planned to enroll 66 patients.


Condition or disease Intervention/treatment
Thyroid Thyroid Cancer Hypoparathyroidism Vascularization Drug: Indocyanine green Device: SPY Portable Handheld Imaging (SPY-PHI)

Detailed Description:

Postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. The incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia.

Although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. Therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands.

The general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal.

In particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. During standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. This technique is used to objectively assess the degree of fluorescence of the parathyroid glands.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Parathyroid Vascularization During Total Thyroidectomy Using Quantitative Real-time Indocyanine Green Angiography
Actual Study Start Date : May 2, 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Surgical group
Patients who undergo thyroid surgery and receive indocyanine green angiography
 Drug: Indocyanine green
Indocyanine green is used to perform intraoperative angiography.

Device: SPY Portable Handheld Imaging (SPY-PHI)
The device is used to perform intraoperative angiography.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Vascularization score [ Time Frame: Intraoperatively ]

    A quantitative score of parathyroid vascularization as an outcome of indocyanine green angiography during thyroidectomy that correlates with the absence of postoperative hypoparathyroidism.

    The score will be reported as a percentage (range 0% - 200%) where the higher score means the better outcome.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Sampling Method:   Non-Probability Sample
Study Population
Inpatients who need surgical treatment for thyroid disease.
Criteria

Inclusion Criteria:

  • Able to sign informed consent
  • Indication to total thyroidectomy
  • No contraindication to indocyanine green administration

Exclusion Criteria:

  • Evidence of parathyroid disease
  • Allergy to iodinated contrast
  • Chronic kidney failure
  • Pregnancy or lactation
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05328076


Locations
Layout table for location information
Italy
San Raffaele Hospital
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Layout table for investigator information
Study Director: Riccardo Rosati, Prof. San Raffaele Hospiral
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Riccardo Maggiore, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT05328076    
Other Study ID Numbers: ANGIO PARA
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Riccardo Maggiore, IRCCS San Raffaele:
Parathyroid
Thyroid surgery
Indocyanine green angiography
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Diseases
Hypoparathyroidism
Neovascularization, Pathologic
Endocrine System Diseases
 Parathyroid Diseases
Metaplasia
Pathologic Processes