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

Primary Purpose

Disc Herniation

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Indocyanine Green
Fluorescence imaging
Sponsored by
Zhongnan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Disc Herniation focused on measuring Disc Herniation, Endoscopy, Indocyanine green, Near-infrared fluorescence imaging, Spinal nerve roots

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control group

0.5mg/kg ICG group

1mg/kg ICG group

2mg/kg ICG group

Arm Description

Standard endoscopic spinal surgery

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.

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.

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.

Outcomes

Primary Outcome Measures

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%
Fluorescence signal ratio of nerve root to back fluorescence
Nerve root fluorescence intensity/Background fluorescence intensity
Time taken to find the nerve root endoscopically
Time from opening the ligamentum flavum to finding the nerve root in spinal endoscopic procedures

Secondary Outcome Measures

ICG-related adverse reactions
Visual analogue pain scale (Visual analogue scale, VAS)
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)
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
Record any surgical complications that occurred in the patient within 1 week after surgery
Length of surgery
Use a timer to record the length of the surgery (accurate to the minute)

Full Information

First Posted
March 16, 2023
Last Updated
April 11, 2023
Sponsor
Zhongnan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05808140
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Herniation
Keywords
Disc Herniation, Endoscopy, Indocyanine green, Near-infrared fluorescence imaging, Spinal nerve roots

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard endoscopic spinal surgery
Arm Title
0.5mg/kg ICG group
Arm Type
Experimental
Arm Description
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.
Arm Title
1mg/kg ICG group
Arm Type
Experimental
Arm Description
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.
Arm Title
2mg/kg ICG group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG
Intervention Description
Preoperatively, a single dose of intravenous indocyanine green is administered
Intervention Type
Device
Intervention Name(s)
Fluorescence imaging
Intervention Description
Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively
Primary Outcome Measure Information:
Title
Fluorescence imaging rate of nerve roots
Description
Number of the nerve roots with fluorescent imaging in the experimental group/Total nerve roots in the experimental group×100%
Time Frame
Intraoperative
Title
Fluorescence signal ratio of nerve root to back fluorescence
Description
Nerve root fluorescence intensity/Background fluorescence intensity
Time Frame
Immediately postoperative
Title
Time taken to find the nerve root endoscopically
Description
Time from opening the ligamentum flavum to finding the nerve root in spinal endoscopic procedures
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
ICG-related adverse reactions
Time Frame
Immediately after ICG administration to 30 min after administration
Title
Visual analogue pain scale (Visual analogue scale, VAS)
Description
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.
Time Frame
1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery
Title
Oswestry disability index(ODI)
Description
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.
Time Frame
1 day before surgery, 1 day after surgery, 1 week after surgery, 1 month after surgery
Title
Surgical complications
Description
Record any surgical complications that occurred in the patient within 1 week after surgery
Time Frame
Within 1 week after surgery
Title
Length of surgery
Description
Use a timer to record the length of the surgery (accurate to the minute)
Time Frame
From the beginning to the end of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanlong Xie, M.D.
Phone
+86 027 67813116
Email
yuanlongxie@whu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanlong Xie, M.D.
Organizational Affiliation
Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430062
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanlong Xie, M.D.
Phone
+86 027 67813116
Email
yuanlongxie@whu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yuanlong Xie, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
26828878
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
27468673
Citation
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.
Results Reference
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PubMed Identifier
29290809
Citation
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.
Results Reference
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PubMed Identifier
33840452
Citation
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.
Results Reference
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PubMed Identifier
25199746
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery

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