Clinical trial NCT05808140: Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery
Official title: Clinical Application of Indocyanine Green Fluorescence Imaging to Assist Identification of Nerve Roots in Endoscopic Spinal Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Disc Herniation
Keywords: Disc Herniation
Endoscopy
Indocyanine green
Near-infrared fluorescence imaging
Spinal nerve roots
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration is time-consuming and critical. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Damage to nerve roots may lead to postoperative sensory retardation and motor weakness, thereby impairing the physical function of patients. A real-time auxiliary intraoperative nerve identification technology is necessary.

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: With the accelerated pace of the global aging society, the prevalence of degenerative diseases is increasing. At present, spinal degenerative diseases caused by body degeneration have become the most common type. With the continuous deepening of the research on spinal degenerative diseases and the continuous development, update and promotion of minimally invasive surgery technology and instruments, minimally invasive surgery has attracted more and more attention of spine surgeons due to its advantages of rapid recovery, small trauma and fewer complications.

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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with lumbar disc herniation based on symptoms and Imaging examination
* 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:

* The patients have thyroid related diseases, including autonomous nodules
* 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

Primary outcomes:
measure: Fluorescence imaging rate of nerve roots
timeFrame: Intraoperative
measure: Fluorescence signal ratio of nerve root to back fluorescence
timeFrame: Immediately postoperative
measure: Time taken to find the nerve root endoscopically
timeFrame: Intraoperative
Secondary outcomes:
measure: ICG-related adverse reactions
timeFrame: Immediately after ICG administration to 30 min after administration
measure: Visual analogue pain scale (Visual analogue scale, VAS)
timeFrame: 1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery
measure: Oswestry disability index（ODI）
timeFrame: 1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery
measure: Surgical complications
timeFrame: Within 1 week after surgery
measure: Length of surgery
timeFrame: From the beginning to the end of the surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
name: Yuanlong Xie, M.D.
role: PRINCIPAL_INVESTIGATOR
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