Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery

Sponsor

Zhongnan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05808140

Collaborator

(none)

Enrollment

Location

Arms

19.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disc Herniation	Drug: Indocyanine Green Device: Fluorescence imaging	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical Application of Indocyanine Green Fluorescence Imaging to Assist Identification of Nerve Roots in Endoscopic Spinal Surgery

Actual Study Start Date :

Apr 11, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group Standard endoscopic spinal surgery
Experimental: 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.	Drug: Indocyanine Green Preoperatively, a single dose of intravenous indocyanine green is administered Other Names: ICG Device: Fluorescence imaging Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively
Experimental: 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.	Drug: Indocyanine Green Preoperatively, a single dose of intravenous indocyanine green is administered Other Names: ICG Device: Fluorescence imaging Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively
Experimental: 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.	Drug: Indocyanine Green Preoperatively, a single dose of intravenous indocyanine green is administered Other Names: ICG Device: Fluorescence imaging Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively

Outcome Measures

Primary Outcome Measures

Fluorescence imaging rate of nerve roots [Intraoperative]
Number of the nerve roots with fluorescent imaging in the experimental group/Total nerve roots in the experimental group×100%
Fluorescence signal ratio of nerve root to back fluorescence [Immediately postoperative]
Nerve root fluorescence intensity/Background fluorescence intensity
Time taken to find the nerve root endoscopically [Intraoperative]
Time from opening the ligamentum flavum to finding the nerve root in spinal endoscopic procedures

Secondary Outcome Measures

ICG-related adverse reactions [Immediately after ICG administration to 30 min after administration]
Visual analogue pain scale (Visual analogue scale, VAS) [1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery]
The VAS pain score uses the VAS scale, with end 0 being no pain, graded 1-4 being mild pain, 5-6 being moderate pain, 7-9 being severe pain, and end 10 being unbearable pain. The higher the score, the more severe the pain level.
Oswestry disability index（ODI） [1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery]
The ODI score is based on the Oswestry Disability Index questionnaire. The lowest score was 0% and the highest score was 100%, with higher scores indicating more severe functional impairment.
Surgical complications [Within 1 week after surgery]
Record any surgical complications that occurred in the patient within 1 week after surgery
Length of surgery [From the beginning to the end of the surgery]
Use a timer to record the length of the surgery (accurate to the minute)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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