NCT06213662 Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia
| NCT ID | NCT06213662 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Zhengzhou University |
| Condition | Cricopharyngeal Achalasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2024-07-01 |
Trial Parameters
Eligibility Fast-Check
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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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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