Clinical trial NCT06213662: Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia
Official title: Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cricopharyngeal Achalasia
Dysphagia
Keywords: Botulinum Toxins
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Oral Intake Scale
timeFrame: pre-treatment、2 weeks after treatment、4 weeks after treatment、24 weeks after treatment
measure: Rosenbek penetration-aspiration scale
timeFrame: pre-treatment、2 weeks after treatment、4 weeks after treatment、24 weeks after treatment
Secondary outcomes:
measure: Murray secretion scale
timeFrame: pre-treatment、2 weeks after treatment
measure: yale pharyngeal residue severity rating scale
timeFrame: pre-treatment、2 weeks after treatment
measure: fiberoptic endoscopic dysphagia severity scale
timeFrame: pre-treatment、2 weeks after treatment
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Yuli Zhu
role: PRINCIPAL_INVESTIGATOR
References: