Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy
NCT ID: NCT06288750
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2024-02-01
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging
NCT07010341
Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
NCT04012476
Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy
NCT02249780
Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
NCT04785443
Intra-operative Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery
NCT02089542
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Indocyanine green group
Identification of parathyroid glands (PGs) Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
Indocyanine Green
ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.
Traditional surgery group
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.
No indocyanine green
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Indocyanine Green
ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.
No indocyanine green
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shandong Linglong Yingcheng Hospital
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xuan Qiu, MD
Role: PRINCIPAL_INVESTIGATOR
Shandong Linglong Yingcheng Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shandong Linglong Yingcheng Hospital
Yantai, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
sdllycyyqx001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.