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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06213662
Other study ID # 2024-KY-0296-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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