Cricopharyngeal AchalasiaNCT06271395
Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction
A study testing Injectable Type A Botulinum Toxin in people with Cricopharyngeal Achalasia, run by Zeng Changhao at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cricopharyngeal Achalasia
- What is being tested?
- Injectable Type A Botulinum Toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Feb 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Xinzhu Rehabilitation Hospital
Xinzhu
Haim Liu
About this study
Official title: The Impact of Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction Under Balloon Localization
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.
Read the 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
- Being tested
- Injectable Type A Botulinum Toxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Type A Botulinum ToxinDrug
Also called 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. 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.
| Study group | Role | What they receive |
|---|---|---|
| The observation group | Experimental | 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. Receives: Drug: Injectable Type A Botulinum Toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional oral intake scale
The Functional Oral Intake Scale (FOIS) is a tool used to assess the functional oral intake of individuals with dysphagia. The scale ranges from Level 1 to Level 7, with Level 1 indicating nothing by mouth and Level 7 representing total oral diet with no restrictions. In this scale, a higher score indicates better functional oral intake capabilities, meaning that higher levels correspond to better oral intake abilities.
Measured: day 1, day 15, day 29, day 169
Secondary outcomes (3)
Penetration-Aspiration Scale
The Penetration-Aspiration Scale (PAS) is a tool used to evaluate the severity of penetration and aspiration events that occur during swallowing. It assesses the extent to which food or liquid enters the airway during swallowing, indicating potential risks to respiratory health.
The PAS ranges from Level 1 to Level 8, with Level 1 representing no penetration or aspiration and Level 8 representing material entering the airway with no effort to eject it. In this scale, a lower score indicates better swallowing function, as lower levels indicate less penetration or aspiration occurring during the swallowing process. It is important to minimize penetration and aspiration events to reduce the risk of respiratory complications and maintain optimal swallowing function.
Measured: day 1, day 15, day 29, day 169
The Fiberoptic Endoscopic Dysphagia Severity Scale
The Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is an instrumental assessment used to evaluate swallowing function. The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) is a tool used to rate the severity of dysphagia based on findings from FEES.
The FEDSS ranges from Level 1 to Level 8, with Level 1 indicating normal swallowing physiology and Level 8 representing severe dysphagia with no protective laryngeal elevation. In this scale, a higher score indicates worse swallowing function, as higher levels indicate more severe dysphagia symptoms.
The FEDSS is used to evaluate various aspects of swallowing function, including the efficiency of swallowing, the coordination between breathing and swallowing, and the presence of pharyngeal residue after swallowing. By identifying the severity of dysphagia using the FEDSS, clinicians can develop appropriate treatment plans to improve swallowing function and reduce the risk of complications.
Measured: day 1, day 15, day 29, day 169
Murray secretion scale
The Murray secretion scale is a commonly used tool to assess the amount and characteristics of respiratory secretions in patients with respiratory diseases or conditions.
It consists of a scoring system ranging from 0 to 4, with 0 indicating no secretions and 4 indicating thick, copious, and tenacious secretions that cannot be cleared.
The scale assesses the color, amount, and viscosity of respiratory secretions, as well as the ease with which they can be cleared. The scale can be useful in monitoring the effectiveness of treatments aimed at reducing sputum production and improving airway clearance.
Measured: day 1, day 15, day 29, day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start28 Feb 2024
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cricopharyngeal AchalasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Study chair, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271395
- Sponsor's protocol ID
- Chaoshengqiunang
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction Under Balloon Localization
- ClinicalTrials.gov ID
- NCT06271395
- Acronym / sponsor ID
- Chaoshengqiunang
- Conditions
- Cricopharyngeal Achalasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The observation group | Experimental | Drug: Injectable Type A Botulinum ToxinThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injectable Type A Botulinum ToxinAlso: Botulinum Toxin InjectionInjectable 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. | Drug | The observation group |
Primary outcome
functional oral intake scale
Time frame: day 1, day 15, day 29, day 169
The Functional Oral Intake Scale (FOIS) is a tool used to assess the functional oral intake of individuals with dysphagia. The scale ranges from Level 1 to Level 7, with Level 1 indicating nothing by mouth and Level 7 representing total oral diet with no restrictions. In this scale, a higher score indicates better functional oral intake capabilities, meaning that higher levels correspond to better oral intake abilities.
3 secondary outcomes
Penetration-Aspiration Scale
Time frame: day 1, day 15, day 29, day 169
The Fiberoptic Endoscopic Dysphagia Severity Scale
Time frame: day 1, day 15, day 29, day 169
Murray secretion scale
Time frame: day 1, day 15, day 29, day 169
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study chair
Site Coordinator of United Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable Type A Botulinum Toxin in people with Cricopharyngeal Achalasia, run by Zeng Changhao at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianyun Lu, Master (15333866454, luqianyun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional oral intake scale (time frame: day 1, day 15, day 29, day 169). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.