Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery
NCT ID: NCT05808140
Last Updated: 2025-12-19
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
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2023-04-11
2025-12-14
Brief Summary
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In this prospective, open-label, randomized, parallel controlled trial, 40 patients who undergo endoscopic spinal surgery are included. Subjects are randomly divided into control group and low, medium and high Indocyanine green(ICG) preoperative administration experimental group. Standard endoscopic spinal surgery is performed in the control group. Patients in the experimental group received an intravenous injection of ICG before surgery, and a standard endoscopic spinal surgery is performed with the use of a fluoroscopic endoscopic surgical imaging system to assist the surgeon in identifying and protecting the nerve roots.
The main objectives of this experiment are (i) to explore the safety and feasibility of ICG fluorescence imaging to assist in nerve root identification during endoscopic spinal surgery and (ii) the effectiveness of this technique for endoscopic search for nerve roots. The secondary objective is to explore the optimal ICG dosing regimen.
Detailed Description
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The core of endoscopic spinal surgery is nerve root decompression. The procedure is centered on the nerve roots, which can be damaged with the slightest carelessness. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Most of the injuries include the stimulation and edema of the nerve root during the operation, which may lead to postoperative sensory retardation and motor weakness, which will damage the patient's physical function and reduce overall satisfaction. The intraoperative nerve exploration is time-consuming and critical, and the variability of the patient's nerve anatomy will also add difficulties to the operation. A real-time auxiliary intraoperative nerve identification technology is necessary.
With the progress of optical technology, fluorescent-guided surgery has shown considerable prospects in assisting in identifying nerves. Indocyanine green (ICG) is the only fluorophore approved by the US Food and Drug Administration (FDA) for intraoperative near-infrared imaging. It can emit near-infrared light after being irradiated by excitation light, which has the characteristics of high penetration depth, low spontaneous fluorescence and high sensitivity. At present, ICG near-infrared fluorescence imaging has been applied to tumor detection, lymphangiography and vascular perfusion evaluation. In recent years, more and more researchers have paid attention to the application value of ICG fluorescence imaging in neuroimaging. It has been applied to clinical research of thoracic sympathetic ganglion, facial nerve, phrenic nerve and pelvic nerve.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Control group
Standard endoscopic spinal surgery
No interventions assigned to this group
0.5mg/kg ICG group
The patients receive 0.5mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures.
Indocyanine Green
Preoperatively, a single dose of intravenous indocyanine green is administered
Fluorescence imaging
Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively
1mg/kg ICG group
The patients receive 1mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures.
Indocyanine Green
Preoperatively, a single dose of intravenous indocyanine green is administered
Fluorescence imaging
Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively
2mg/kg ICG group
The patients receive 2mg/kg ICG intravenous injection before surgery. The search for lumbar nerve roots is performed with the assistance of fluoroscopic endoscopic imaging equipment. And the procedure follows standard endoscopic spinal surgery procedures.
Indocyanine Green
Preoperatively, a single dose of intravenous indocyanine green is administered
Fluorescence imaging
Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively
Interventions
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Indocyanine Green
Preoperatively, a single dose of intravenous indocyanine green is administered
Fluorescence imaging
Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergo endoscopy spinal surgery for nerve root decompression
* Patients have no clear contraindications to surgery, and has the ability to understand and act and has informed consent, and can participate in all study follow-up voluntarily and signe a written informed consent form.
Exclusion Criteria
* Patients are allergic to iodine or shellfish
* Patients have ankylosing spondylitis, lumbar instability or bony spinal stenosis
* Patients have diabetes, vascular related diseases, or abnormal liver and kidney function
* Difficulty in tolerating anaesthesia
* Pregnant or lactating women
* Patients are unable to communicate or do not follow directions
* The investigators consider the patient unsuitable to participate in this study
20 Years
60 Years
ALL
No
Sponsors
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Zhongnan Hospital
OTHER
Responsible Party
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Yuanlong Xie
Principal Investigator
Principal Investigators
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Yuanlong Xie, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
Locations
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Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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References
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Gokaslan ZL, Telfeian AE, Wang MY. Introduction: Endoscopic spine surgery. Neurosurg Focus. 2016 Feb;40(2):E1. doi: 10.3171/2015.11.FOCUS15597. No abstract available.
Fourney DR, Dettori JR, Norvell DC, Dekutoski MB. Does minimal access tubular assisted spine surgery increase or decrease complications in spinal decompression or fusion? Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S57-65. doi: 10.1097/BRS.0b013e3181d82bb8.
Strakowski JA. Ultrasound-Guided Peripheral Nerve Procedures. Phys Med Rehabil Clin N Am. 2016 Aug;27(3):687-715. doi: 10.1016/j.pmr.2016.04.006. Epub 2016 Jun 6.
He K, Zhou J, Yang F, Chi C, Li H, Mao Y, Hui B, Wang K, Tian J, Wang J. Near-infrared Intraoperative Imaging of Thoracic Sympathetic Nerves: From Preclinical Study to Clinical Trial. Theranostics. 2018 Jan 1;8(2):304-313. doi: 10.7150/thno.22369. eCollection 2018.
Kanno K, Aiko K, Yanai S, Sawada M, Sakate S, Andou M. Clinical use of indocyanine green during nerve-sparing surgery for deep endometriosis. Fertil Steril. 2021 Jul;116(1):269-271. doi: 10.1016/j.fertnstert.2021.03.014. Epub 2021 Apr 8.
Chen SC, Wang MC, Wang WH, Lee CC, Yang TF, Lin CF, Wang JT, Liao CH, Chang CC, Chen MH, Shih YH, Hsu SP. Fluorescence-assisted visualization of facial nerve during mastoidectomy: A novel technique for preventing iatrogenic facial paralysis. Auris Nasus Larynx. 2015 Apr;42(2):113-8. doi: 10.1016/j.anl.2014.08.008. Epub 2014 Sep 6.
He K, Li P, Zhang Z, Liu J, Liu P, Gong S, Chi C, Liu P, Chen C, Tian J. Intraoperative near-infrared fluorescence imaging can identify pelvic nerves in patients with cervical cancer in real time during radical hysterectomy. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2929-2937. doi: 10.1007/s00259-022-05686-z. Epub 2022 Mar 1.
Other Identifiers
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Yuanlong Xie
Identifier Type: -
Identifier Source: org_study_id