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

NCT05808140 | Completed Phase 1

• 1 other identifier: Yuanlong Xie
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Disc Herniation

Keywords

Disc Herniation; Endoscopy; Indocyanine green; Near-infrared fluorescence imaging; Spinal nerve roots

Outcome Measures

Primary Outcomes (3)

• Fluorescence imaging rate of nerve roots

  Number of the nerve roots with fluorescent imaging in the experimental group/Total nerve roots in the experimental group×100%

  Intraoperative

• Fluorescence signal ratio of nerve root to back fluorescence

  Nerve root fluorescence intensity/Background fluorescence intensity

  Immediately postoperative

• Time taken to find the nerve root endoscopically

  Time from opening the ligamentum flavum to finding the nerve root in spinal endoscopic procedures

  Intraoperative

Secondary Outcomes (5)

• 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

• Oswestry disability index（ODI）

  1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery

• Surgical complications

  Within 1 week after surgery

• Length of surgery

  From the beginning to the end of the surgery

Study Arms (4)

Control group

NO INTERVENTION

Standard endoscopic spinal surgery

0.5mg/kg ICG group

EXPERIMENTAL

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; Device: Fluorescence imaging

1mg/kg ICG group

EXPERIMENTAL

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; Device: Fluorescence imaging

2mg/kg ICG group

EXPERIMENTAL

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; Device: Fluorescence imaging

Interventions

Indocyanine Green DRUG

Preoperatively, a single dose of intravenous indocyanine green is administered

Also known as: ICG

0.5mg/kg ICG group; 1mg/kg ICG group; 2mg/kg ICG group

Fluorescence imaging DEVICE

Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively

0.5mg/kg ICG group; 1mg/kg ICG group; 2mg/kg ICG group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

Location

Related Publications (7)

• 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.

  PMID: 26828878 BACKGROUND

• 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.

  PMID: 20407352 BACKGROUND

• 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.

  PMID: 27468673 BACKGROUND

• 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.

  PMID: 29290809 BACKGROUND

• 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.

  PMID: 33840452 BACKGROUND

• 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.

  PMID: 25199746 BACKGROUND

• 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.

  PMID: 35230489 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Indocyanine Green; Optical Imaging

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Yuanlong Xie, M.D.

  Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 11, 2023
• Study Start: April 11, 2023
• Primary Completion: December 14, 2025
• Study Completion: December 14, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CN (1)