Botulinum toxin injection with ultrasound guidance for cricopharyngeal achalasia
Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia
This study is testing if ultrasound-guided botulinum toxin injections can help people with cricopharyngeal achalasia swallow better when standard treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Zhengzhou) |
| Trial ID | NCT06213662 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of botulinum toxin type A injections, guided by ultrasound and combined with balloon localization, to treat cricopharyngeal achalasia, a condition that impairs swallowing. Patients who have not improved with standard rehabilitation therapy will receive targeted injections to relieve muscle spasms in the cricopharyngeal muscle. Additionally, participants will undergo daily swallowing training to enhance their swallowing function. The goal is to improve the quality of life for patients suffering from dysphagia due to this condition.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with cricopharyngeal achalasia who have not seen improvement after at least two weeks of rehabilitation therapy.
Not a fit: Patients with severe cognitive impairment, mental illness, or significant cardiopulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve swallowing function and quality of life for patients with cricopharyngeal achalasia.
How similar studies have performed: Other studies have shown promising results using botulinum toxin for similar conditions, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhengzhou
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)
Study contacts
- Principal investigator: Yuli Zhu — The First Affiliated Hospital of Zhengzhou University
- Study coordinator: Yuli Zhu
- Email: 15351370521@163.com
- Phone: +8615351370521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.