Status:
RECRUITING
Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Cricopharyngeal Achalasia
Dysphagia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 mus...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06213662
Start Date
November 1 2022
End Date
July 1 2024
Last Update
May 16 2024
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China