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Total ThyroidectomyNCT06288750

Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy

A study testing Indocyanine Green and No indocyanine green in people with Total Thyroidectomy and Parathyroid Function Low Adverse Event, run by Shandong Linglong Yingcheng Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Indocyanine Green and No indocyanine green
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 Feb 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female patients, aged 18 years and above
  • Scheduled for elective total or hemi thyroidectomy
  • Normal liver and renal function
  • No known hypersensitivity for iodine or ICG
  • Able to understand the nature of the study procedures
  • Willing to participate and give written informed consent

Who cannot join

  • Age < 18 years
  • Liver or renal insufficiency
  • Known ICG, iodine, penicillin or sulfa hypersensitivity
  • Pregnancy or breastfeeding
  • Not able to understand the nature of the study procedure
  • Not willing to participate

Trial locations and contacts

1 site in 1 country.

Ni Wang, MD,PD contact

8618705353551

wangni1989@163.com

China1 site, 1 recruiting
  • Shandong Linglong Yingcheng Hospital

    Yantai, Shandong, 264000

    Xuan Qiu, MD, 8618354280081, qiuxuan100@163.com

    Ni Wang, MD, 8618705353551, wangni1989@163.com

    Recruiting

Other trials in China

About this study

Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy.

Read the detailed description

Postoperative hypoparathyroidism or hypocalcemia is the most frequent complication after total thyroidectomy (TT) . The median incidence of transient and permanent postoperative hypoparathyroidism is 27% (19%-38%) and 1% (0-3%), respectively. Transient hypoparathyroidism can increase the length of hospital stay and the costs of hospitalization for patients. Permanent hypoparathyroidism leads to lifelong medication use, which may severely impair the quality of life of patients. Therefore, identifying the parathyroid glands (PGs) and preserving those with adequate blood perfusion intraoperatively has always been a crucial procedure during thyroidectomy.

Conventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance (color, shape, etc.) by the naked eye. However, this visual inspection is often influenced by the experience of the surgeon, intraoperative hemorrhage, ectopic PGs and so on, which makes it difficult to fully protect the PGs.

Currently, there has been an emergence of near-infrared fluorescence imaging (NIFI) that can be applied during thyroid or parathyroid surgery for the evaluation and identification of PGs. This technique mainly exploits the autofluorescence (AF) of PGs and indocyanine green fluorescence (ICGF ) imaging.PGs could exhibit stronger AF than the surrounding tissue under near-infrared light, which can be exploited to accurately identify PGs in real time. Subsequent studies have demonstrated that AF can not only detect PGs intraoperatively in real time and improve the intraoperative identification of PGs but also reduce the incidence of postoperative hypoparathyroidism. However, AF cannot assess the status of PG blood perfusion and consequently is not useful when determining whether PGs need to be autotransplanted.

Indocyanine green (ICG) fluorescence imaging may be a great solution to this problem. ICG is a safe fluorescent dye with fast metabolism and few adverse effects that can quickly combine with plasma proteins after intravenous injection and is widely used in angiography in multiple surgical disciplines. In recent years, several studies have shown that ICGF may be superior in evaluating blood perfusion and predicting the function of PGs in situ, subsequently guiding their autotransplantation. However, ICGF may not be very suitable for the identification of PGs before dissection, as the thyroid gland would also emit intense fluorescence after the injection of ICG, which may lead to difficulties in distinguishing them. Thus, AF and ICGF have their own advantages and disadvantages in the identification and evaluation of PGs, respectively. These two methods can be considered complementary.

In the present study, the investigators used AF in combination with ICGF imaging by one fluorescence imaging system during different steps of the surgical procedure. At the beginning of the operation, AF was used to identify the PGs before any dissection. Then, after the thyroid gland was removed, AF was used again to locate the PGs in situ. Finally, ICGF was applied to evaluate the blood perfusion of the PGs in situ and guide their autotransplantation. The aim of this randomized controlled trial was to assess whether this strategy could reduce the incidence of postoperative hypoparathyroidism and benefit the identification and evaluation of PGs during total thyroidectomy.

Being tested
Indocyanine Green, No indocyanine green
Medical subject headings
Parathyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine GreenDevice

    Also called Near Infrared Fluorescence Imaging

    ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.

  • No indocyanine greenDevice

    Conventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance (color, shape, etc.) by the naked eye.

Study groups in NCT06288750
Study groupRoleWhat they receive
Indocyanine green groupExperimentalIdentification of parathyroid glands (PGs) Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
Receives: Device: Indocyanine Green
Traditional surgery groupActive comparatorConventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance (color, shape, etc.) by the naked eye.
Receives: Device: No indocyanine green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast

    İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)

    Measured: 1 year

Secondary outcomes (1)
  1. Central lymph node dissetion (CLND)

    Number of positive lymph nodes (micrometastases)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06288750
Sponsor's protocol ID
sdllycyyqx001
Status last verified
Mar 2024
First submitted
25 Feb 2024
Last updated
5 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Indocyanine Green and No indocyanine green in people with Total Thyroidectomy and Parathyroid Function Low Adverse Event, run by Shandong Linglong Yingcheng Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xuan Qiu, MD (8618354280081, qiuxuan100@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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