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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213662
• Other study ID #: 2024-KY-0296-001
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Yuli Zhu
• Phone: +8615351370521
• Email: 15351370521[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysphagia
• Esophageal Achalasia

Intervention

Drug:
• Botulinum toxin type A for injection
Botulinum toxin was injected into the upper esophageal sphincter of each patient

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Oral Intake Scale	According to whether the patient can eat by mouth and the degree of dependence on nasal feeding tube, it is divided into 7 grades, corresponding to 1-7 points respectively. The higher the score, the better the swallowing function.	pre-treatment?2 weeks after treatment?4 weeks after treatment?24 weeks after treatment
Primary	Rosenbek penetration-aspiration scale	Based on the results of Videofluroscopic swallowing study (VFSS), the cases of leakage and aspiration were divided into 8 grades, corresponding to 1-8 points respectively. The higher the score, the better the swallowing function.	pre-treatment?2 weeks after treatment?4 weeks after treatment?24 weeks after treatment
Secondary	Murray secretion scale	Based on Fiberoptic endoscopic evaluation of swallowing (FEES), the accumulation position of oropharyngeal secretions was described and divided into 4 grades. The higher the score, the worse the swallowing function.	pre-treatment?2 weeks after treatment
Secondary	yale pharyngeal residue severity rating scale	Based on Fiberoptic endoscopic evaluation of swallowing (FEES), the main indicators include the location of the residue (epiglottic valley and pyriform sinus) and the amount of residue, which is divided into 5 grades. The higher the score, the worse the swallowing function.	pre-treatment?2 weeks after treatment
Secondary	fiberoptic endoscopic dysphagia severity scale	Based on Fiberoptic endoscopic evaluation of swallowing (FEES), Eat different foods and observe whether penetration aspiration and protective reflex occur. The highest score is 6, which means that saliva accumulates with penetration or aspiration, and the lowest score is 1. When eating soft solid food, there is no leakage or aspiration, and there is little or moderate residue in epiglottic valley or pyriform sinus. The higher the score, the worse the swallowing function.	pre-treatment?2 weeks after treatment