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

NCT06213662 | Recruiting

• 1 other identifier: 2024-KY-0296-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cricopharyngeal Achalasia; Dysphagia

Keywords

Botulinum Toxins

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Murray secretion scale

  pre-treatment、2 weeks after treatment

• yale pharyngeal residue severity rating scale

  pre-treatment、2 weeks after treatment

• fiberoptic endoscopic dysphagia severity scale

  pre-treatment、2 weeks after treatment

Study Arms (1)

experimental group

EXPERIMENTAL

Botulinum toxin type A for injection (Hengli National Drug approval number S10970037) 100U, diluted with 1 ml.9% sodium chloride solution for reserve use.Each patient was injected with 90U

Drug: Botulinum toxin type A for injection

Interventions

Botulinum toxin type A for injection DRUG

Botulinum toxin was injected into the upper esophageal sphincter of each patient

Also known as: Botulinum toxin type A for injection (Hengli National Drug approval number S10970037)

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Botulinum Toxins, Type A; Injections

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yuli Zhu

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuli Zhu

CONTACT

+8615351370521; 15351370521@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: November 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)