Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05808140
Study type Interventional
Source Zhongnan Hospital
Contact Yuanlong Xie, M.D.
Phone +86 027 67813116
Email yuanlongxie@whu.edu.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date April 11, 2023
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT06006377 - Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies N/A
Terminated NCT01267825 - CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial Phase 4
Active, not recruiting NCT06141551 - Intradural Disc Herniation: a Case Report and Review of Complications
Recruiting NCT05732818 - Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3 N/A
Recruiting NCT06023719 - Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence N/A
Enrolling by invitation NCT06415136 - Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
Completed NCT05687305 - The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery N/A
Completed NCT05803954 - Mobilization With Movement vs. Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy N/A
Not yet recruiting NCT06275529 - Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification N/A
Completed NCT05680142 - Regional Analgesia for Anterior Cervical Disc and Fusion Surgery N/A
Completed NCT06448416 - Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies
Not yet recruiting NCT05999565 - Investigation of the Effect of Motor Imagery Training in Individuals With Cervical Discogenic Pain N/A
Recruiting NCT05695014 - Effect of Discharge Education on Discharge Readiness and Satisfaction N/A
Completed NCT05753579 - Is Regression Possible in Lumbal Disc Herniation With Spinal Mobilization Applications? N/A
Recruiting NCT05306665 - PREventing Pain After Surgery N/A
Recruiting NCT06453499 - Silent Lumbar Disc Herniation Syndrome
Not yet recruiting NCT06178939 - Effects of Cognitive Intervention Therapy on Postoperative Delirium N/A
Enrolling by invitation NCT05745129 - Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders
Completed NCT06046781 - Exercise After Lumbar Disc Herniation Surgery N/A