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Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Thyroidectomy

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ClinicalTrials.gov Identifier: NCT05130476
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Sanne Høxbroe Michaelsen, Odense University Hospital

Brief Summary:
The parathyroid glands and their blood vessels are notoriously difficult to visualize and may therefore be unintentionally and irrevocably damaged during thyroid surgery. This project investigates new surgeon-performed imaging techniques that visualize the parathyroid glands and their vessels in real-time during thyroid surgery. The purpose is to examine, in a matched cohort study, whether the implementation of near-infrared-induced autofluorescence for identification of the parathyroid glands, combined with indocyanine green near-infrared angiography of the parathyroid feeding vessels, can reduce the incidence of postoperative hypocalcaemia in patients undergoing total and completion thyroidectomy at Odense University Hospital.

Condition or disease Intervention/treatment Phase
Hypoparathyroidism Postprocedural Procedure: Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography Not Applicable

Detailed Description:

The most common complication after thyroidectomy is postoperative hypoparathyroidism due to unintentional intraoperative injury, excision, or devascularisation of the parathyroid glands. This complication can be either transient (≤6 months), or permanent (> 6 months). The pooled results from four recent studies from three different Danish university hospitals show that 117/945 patients (12.4%) suffered from permanent hypoparathyroidism after total and completion thyroidectomy. This is a very high percentage, considering that the consequences of hypoparathyroidism and its treatment may be severe and include prolonged hospitalization, neuromuscular symptoms, nephrocalcinosis, nephrolithiasis, premature cataracts, seizures, basal ganglia calcification, and increased mortality.

To minimize the risk of postoperative hypoparathyroidism, the standard approach to thyroidectomy is to keep dissection as close to the thyroid capsule as possible while visually scrutinizing the surgical field for the parathyroid glands and their delicate feeding vessels. In spite of these measures, the reported incidences of transient and permanent hypocalcaemia clearly demonstrate a need to further decrease the risk of inadvertent injury to the parathyroid glands and their vessels during thyroid surgery. To achieve this goal, surgeons need a reliable intraoperative aid that can 1) help them identify the parathyroid glands in vivo and 2) locate their feeding vessels and evaluate their perfusion in real-time during thyroid surgery. Recently, two near-infrared fluorescence techniques have emerged, that could potentially meet the requirement of identifying the parathyroid glands and assessing their vasculature using the same piece of technical equipment. The techniques are: near-infrared-induced autofluorescence of the parathyroid glands (NIRAF) for parathyroid identification, and indocyanine green near-infrared angiography (ICGA) for the assessment of parathyroid vascularization. A recent systematic review concluded that these most reported-on optical tools for parathyroid identification and perfusion assessment are favourable for clinical application in terms of being real-time and non-invasive, having a high sensitivity, an excellent safety profile, and involving no exposure to ionizing radiation. Prior to a broader implementation, commercially unaffiliated investigator-initiated studies are needed to evaluate the clinical effect of the bimodal application of NIRAF and ICGA on the incidence of postoperative hypoparathyroidism after total and completion thyroidectomy. This study intends to address this need.

The hypothesis of the study is that near-infrared-induced autofluorescence (NIRAF) combined with indocyanine green near-infrared angiography (ICGA) of the parathyroid glands can reduce the incidence of permanent hypoparathyroidism after total and completion thyroidectomy to 1/3 or less of the incidence in a matched retrospective control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 139 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Matched cohort study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intraoperative Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Total and Completion Thyroidectomy: a Matched Cohort Study
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NIRAF+ICGA
During thyroid surgery, near-infrared-induced autofluorescence is used for the identification of the parathyroid glands, combined with indocyanine green near-infrared angiography for identification of the parathyroid feeding vessels.
Procedure: Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography
During thyroid surgery, near-infrared-induced autofluorescence is used for the identification of the parathyroid glands, combined with indocyanine green near-infrared angiography for identification of the parathyroid feeding vessels.




Primary Outcome Measures :
  1. Permanent hypoparathyroidism 12 months after surgery [ Time Frame: 12 months postoperatively ]
    The number of participants in the study cohort with permanent hypoparathyroidism 12 months after treatment compared to the number of participants with permanent hypoparathyroidism 12 months after treatment in a matched retrospective cohort from the same hospital that underwent surgery without NIRAF+ICGA.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Patients 18 years and older who are scheduled to undergo total or completion thyroidectomy at the department of Oro-Rhino-Laryngology (ORL) and Head and Neck Surgery at Odense University Hospital, Denmark.

Exclusion Criteria:

  • Not legally competent.
  • Does not read or speak Danish.
  • Is pregnant or nursing.
  • Suffers from chronic kidney disease with an estimated glomerular filtration rate < 45 ml/min/1.73m2.
  • Has a history of allergy to iodides or to indocyanine green.
  • Suffers from hyperparathyroidism, hypoparathyroidism, or hypocalcaemia prior to surgery.
  • Prescription use of supplemental active vitamin D: dihydrotachysterol (ATC 11CC02), alfacalcidol (ATC A11CC03), or calcitriol (ATC A11CC04).
  • Patients scheduled to have a radioactive iodine uptake study performed ≤ 7 days after the thyroidectomy.

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): NCT05130476


Contacts
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Contact: Sanne H Michaelsen, MD +4565412800 sanne.hoxbroe.michaelsen@rsyd.dk

Locations
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Denmark
Odense University Hospital Recruiting
Odense C, Denmark, 5000
Contact: Sanne H Michaelsen, MD    +4565412800    sanne.hoxbroe.michaelsen@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Additional Information:
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Responsible Party: Sanne Høxbroe Michaelsen, Principal investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT05130476    
Other Study ID Numbers: S-20200154
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanne Høxbroe Michaelsen, Odense University Hospital:
Near-infrared fluorescence
Additional relevant MeSH terms:
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Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases