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临床试验/NCT07400055
NCT07400055尚未招募不适用

Evaluation of Medulla Spinalis Edema After CT-Guided Percutaneous Cervical Cordotomy Using Magnetic Resonance Imaging and Its Association With Postprocedural Clinical Outcomes in Patients With Cancer Pain

Mersin University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
试验地点
1
主要终点
Presence and extent of spinal cord edema on cervical MRI after CT-guided percutaneous cordotomy

研究概览

简要总结

This observational study aims to evaluate changes in the spinal cord following CT-guided percutaneous cervical cordotomy performed for the treatment of intractable cancer-related pain. Cordotomy is a routine clinical procedure used to relieve severe pain in selected cancer patients. After the procedure, some patients may develop temporary neurological symptoms that are thought to be related to spinal cord edema.

In this study, magnetic resonance imaging (MRI) will be performed as part of routine clinical follow-up on postoperative day 1 and at 1 month to assess the presence and extent of spinal cord edema. Clinical outcomes, including pain intensity and possible postprocedural symptoms, will be recorded and compared with MRI findings.

The goal of this research is to better understand the relationship between imaging changes in the spinal cord and clinical outcomes after cordotomy, which may help improve patient care and postoperative management in the future.

详细描述

Percutaneous cervical cordotomy is a well-established palliative procedure used for the management of severe unilateral cancer-related pain that is refractory to medical treatment. The procedure involves CT-guided placement of a radiofrequency electrode at the C1-C2 level to create a lesion in the anterolateral spinothalamic tract, resulting in effective pain relief. Despite its efficacy, transient neurological effects such as dysesthesia, sensory disturbances, and neuropathic pain may occur following the procedure. These clinical findings are believed to be associated with postoperative changes in the spinal cord, including edema.

This prospective observational study is designed to evaluate the presence and extent of medulla spinalis edema following CT-guided percutaneous cervical cordotomy and to investigate its association with clinical outcomes.

A total of 10 to 15 adult patients with cancer-related pain who undergo cordotomy as part of routine clinical care at Mersin University Faculty of Medicine Algology Clinic will be enrolled. Eligible patients will be those aged 18 years or older with an indication for cordotomy.

All procedures will be performed under CT guidance at the C2 level using radiofrequency ablation with standard clinical parameters. No additional interventions will be applied for research purposes.

Clinical assessments will include baseline pain intensity measured using a numeric rating scale (NRS), postoperative pain scores, and evaluation of potential neurological symptoms such as dysesthesia, sensory loss, and other transient complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and older
  • Patients with cancer-related pain refractory to medical treatment
  • Patients scheduled to undergo CT-guided percutaneous cervical cordotomy as part of routine clinical care
  • Ability to provide informed consent
  • Availability for postoperative MRI follow-up on day 1 and at 1 month

排除标准

  • Patients younger than 18 years
  • Patients without an indication for percutaneous cervical cordotomy
  • Inability to undergo MRI (e.g., incompatible implants, severe claustrophobia)
  • Patients who decline participation or withdraw consent
  • Incomplete clinical or imaging follow-up data

研究组 & 干预措施

Percutaneous Cervical Cordotomy Cohort

Adult patients with cancer-related pain undergoing routine CT-guided percutaneous cervical cordotomy and followed with postoperative MRI and clinical assessments.

干预措施: CT-guided Percutaneous Cervical Cordotomy (Procedure)

结局指标

主要结局

Presence and extent of spinal cord edema on cervical MRI after CT-guided percutaneous cordotomy

时间窗: Postoperative day 1 and 1 month

Spinal cord edema will be evaluated on cervical MRI by a single radiologist, including presence, location, and longitudinal extent of edema.

次要结局

  • Change in pain intensity measured by Numeric Rating Scale (NRS)(Baseline, postoperative day 1, and 1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mesut Bakır

Associate Professor of Anesthesiology and Algology

Mersin University

研究点 (1)

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