Actively Recruiting
Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2024-05-16
20
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Videofluoroscopic swallowing study confirmed cricopharyngeal muscle is not opening or closing
- No significant improvement in swallowing after more than 2 weeks of standardized rehabilitation therapy
- Presence of swallowing initiation with upward motion of the hyoid greater than half the height of the C3 cone on VFSS
- Stable vital signs, conscious, and cooperative with treatment
- Patient or family voluntarily signed written informed consent
You will not qualify if you...
- Severe cognitive impairment, mental illness, or severe cardiopulmonary disease
- Abnormal throat structure
- Presence of malignant tumor
- Infection or wound at the injection site
- Allergy to botulinum toxin
- Bleeding tendency or coagulation disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
Y
Yuli Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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