Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Functional Oral Intake Scale
研究概览
简要总结
cricopharyngeal achalasia refers to incomplete or non-open functional opening of the cricopharyngeal muscle, and after repeated swallowing of food, it still cannot pass through the cricopharyngeal muscle, remaining in the epiglottic valley and the piriform fossa, and even regurgitated into the nasal cavity . Neurogenic diseases, myogenic diseases and head and neck tumors are the common causes. Patients with chronic underfeeding lead to malnutrition, reduced quality of life, affecting the outcome of the disease. At present, the treatment measures for cricopharyngeal achalasia at home and abroad include balloon dilation technique, surgical incision, botulinum toxin injection. The dilation of the balloon is easy to cause mucosal edema and damage. Local infection, massive hemorrhage, local nerve injury and other complications often occur in cricopharyngotomy. Botulinum toxin injection relieves muscle spasms and is now widely used to treat dystonia. Common injection localization methods include CT, ultrasound, electromyography and endoscopy. Ultrasound-guided injection is a new technique of visualization, simple and non-radiation injection guidance, which can observe the injection process and drug injection position in real time. Fixation with a balloon can further improve the accuracy of the injection. In this study, botulinum toxin was injected into the cricopharyngeal muscle by ultrasound combined with balloon.
详细描述
Under the ultrasound combined with balloon fixation, two injection sites were selected from the left upper esophageal sphincter, and 30U was injected respectively, and one injection site was selected from the right side, and 30U was injected. In addition, the patient also received routine swallowing training once a day for 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The videofluoroscopic swallowing study (VFSS) confirmed that the cricopharyngeal muscle was not open/closed
- •Patients with no significant improvement in swallowing function after more than 2 weeks of standardized rehabilitation therapy (FOIS unchanged or decreased)
- •In the presence of swallowing initiation, VFSS is seen in swallowing with an upward motion of the hyoid greater than half the height of the C3 cone
- •Vital signs stable, conscious, treatment cooperative
- •The patient himself or his family members sign the written informed consent voluntarily
排除标准
- •Patients with severe cognitive impairment, mental illness, and severe cardiopulmonary disease
- •The structure of the throat is abnormal
- •Malignant tumor patient
- •Infection or wound at the injection site
- •People allergic to botulinum toxin
- •Bleeding tendency and coagulation disorder
研究组 & 干预措施
experimental group
Botulinum toxin type A for injection (Hengli National Drug approval number S10970037) 100U, diluted with
1 ml.9% sodium chloride solution for reserve use.Each patient was injected with 90U
干预措施: Botulinum toxin type A for injection (Drug)
结局指标
主要结局
Functional Oral Intake Scale
时间窗: pre-treatment、2 weeks after treatment、4 weeks after treatment、24 weeks after treatment
According to whether the patient can eat by mouth and the degree of dependence on nasal feeding tube, it is divided into 7 grades, corresponding to 1-7 points respectively. The higher the score, the better the swallowing function.
Rosenbek penetration-aspiration scale
时间窗: pre-treatment、2 weeks after treatment、4 weeks after treatment、24 weeks after treatment
Based on the results of Videofluroscopic swallowing study (VFSS), the cases of leakage and aspiration were divided into 8 grades, corresponding to 1-8 points respectively. The higher the score, the better the swallowing function.
次要结局
- yale pharyngeal residue severity rating scale(pre-treatment、2 weeks after treatment)
- Murray secretion scale(pre-treatment、2 weeks after treatment)
- fiberoptic endoscopic dysphagia severity scale(pre-treatment、2 weeks after treatment)
研究者
Yuli Zhu
Principal Investigator
The First Affiliated Hospital of Zhengzhou University