NCT06213662

Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cricopharyngeal Achalasia
• Dysphagia

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A for injection	Botulinum toxin was injected into the upper esophageal sphincter of each patient

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2024-01-19
• Last updated: 2024-05-16

Locations

1 site across 1 country: China