Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06213662

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

Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2024-05-16

20

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Videofluoroscopic swallowing study confirmed cricopharyngeal muscle is not opening or closing
  • No significant improvement in swallowing after more than 2 weeks of standardized rehabilitation therapy
  • Presence of swallowing initiation with upward motion of the hyoid greater than half the height of the C3 cone on VFSS
  • Stable vital signs, conscious, and cooperative with treatment
  • Patient or family voluntarily signed written informed consent
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment, mental illness, or severe cardiopulmonary disease
  • Abnormal throat structure
  • Presence of malignant tumor
  • Infection or wound at the injection site
  • Allergy to botulinum toxin
  • Bleeding tendency or coagulation disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Actively Recruiting

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Research Team

Y

Yuli Zhu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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