Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction

NCT ID: NCT06271395

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2024-10-31

Brief Summary

Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

Detailed Description

The patient's long-term inadequate food intake leads to malnutrition, decreased quality of life, and impacts the prognosis of the disease. Currently, both domestically and internationally, treatment options for cricopharyngeal muscle dysfunction include balloon dilation technique, surgical incision, and botulinum toxin injection. Passive dilation with a balloon can easily cause mucosal edema and damage. Cricopharyngeal myotomy surgery often presents complications such as local infection, excessive bleeding, and local nerve damage. Botulinum toxin can alleviate muscle spasms and has been widely used in the treatment of hypertonic disorders [3]. Common injection localization methods include ultrasound, electromyography, and endoscopy. Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. Combining it with balloon fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

Conditions

Cricopharyngeal Achalasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The observation group

This group will be given Left cricopharyngeal muscle botulinum toxin injection, Injectable Type A Botulinum Toxin (National Medical Products Administration Approval Number S10970037) 100 unit, diluted with 1ml of 0.9% sodium chloride solution for injection and kept ready for use. Only once.

Group Type: EXPERIMENTAL

Injectable Type A Botulinum Toxin

Intervention Type: DRUG

Injectable Type A Botulinum Toxin (National Medical Products Administration Approval Number S10970037) 100 unit, diluted with 1ml of 0.9% sodium chloride solution for injection and kept ready for use. Only once. Using an ultrasound probe to scan the neck, the position of the lowest point, highest point, and lower middle point of the esophageal high-pressure zone are determined, and marks are made on the body surface and catheter wall. The high-pressure point and the lower middle point are selected as injection sites on the left side. The above area is locally disinfected, and the probe is covered with a sterile cover and coated with sterile coupling agent. Using a plane approach, 0.3ml or 30 unit of botulinum toxin is injected separately after reaching the esophageal circular layer at each of the two left injection points. A total of 60 unit of botulinum toxin is injected at the two left points.

Interventions

Injectable Type A Botulinum Toxin

Injectable Type A Botulinum Toxin (National Medical Products Administration Approval Number S10970037) 100 unit, diluted with 1ml of 0.9% sodium chloride solution for injection and kept ready for use. Only once. Using an ultrasound probe to scan the neck, the position of the lowest point, highest point, and lower middle point of the esophageal high-pressure zone are determined, and marks are made on the body surface and catheter wall. The high-pressure point and the lower middle point are selected as injection sites on the left side. The above area is locally disinfected, and the probe is covered with a sterile cover and coated with sterile coupling agent. Using a plane approach, 0.3ml or 30 unit of botulinum toxin is injected separately after reaching the esophageal circular layer at each of the two left injection points. A total of 60 unit of botulinum toxin is injected at the two left points.

Intervention Type: DRUG

Other Intervention Names

Botulinum Toxin Injection

Eligibility Criteria

Inclusion Criteria

• Videofluoroscopic swallowing study (VFSS) confirming incomplete/opening dysfunction of the cricopharyngeal muscle;
• No significant improvement in swallowing function after standardized rehabilitation treatment for more than 2 weeks (unchanged or decreased FOIS);
• Presence of swallowing initiation, with VFSS showing that the upward movement of the hyoid bone during swallowing is greater than half the height of the C3 vertebral body;
• Stable vital signs, alert consciousness, and cooperation with treatment;

Exclusion Criteria

• Patients with severe cognitive impairments, psychiatric disorders, and severe cardiopulmonary diseases;
• Abnormalities in the pharynx and larynx structures;
• Patients with malignant tumors;
• Patients with infections or wounds at the injection site;
• Patients allergic to botulinum toxin; Patients with bleeding tendencies or coagulation disorders.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeng Changhao

OTHER

Sponsor Role: lead

Responsible Party

Zeng Changhao

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis, Master

Role: STUDY_CHAIR

Site Coordinator of United Medical Group

Locations

Xinzhu Rehabilitation Hospital

Xinzhu, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Qianyun Lu, Master

Role: CONTACT

luqianyun@126.com

15333866454

Weiji Zhao, Master

Role: CONTACT

zwjww2009@163.com

17839973473

Facility Contacts

Haim Liu

Role: primary

Other Identifiers

Chaoshengqiunang

Identifier Type: -

Identifier Source: org_study_id