Botulinum Toxin Injection in Hypercontractile Esophagus
NCT ID: NCT01955174
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2013-08-31
2018-02-28
Brief Summary
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Detailed Description
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This is a prospective, randomized, double blind, controlled trial comparing BTX injection to sham procedure (absence of injection, the clinical team performing the follow-up will not be aware of the result of the randomization).
Drugs which could affect esophageal motility (nitrates and calcium channel blockers) will be stopped during the study.
Included patients will undergo esophageal endoscopic ultrasound examination (EEUS) and upper gastrointestinal endoscopy under general anesthesia. In absence of contraindications, patients will be randomized in two arms: BTX injection or no injection. The active treatment group will receive 100 units of type A BTX (Botox®, Allergan) diluted in 10 mL of saline serum; BTX will be injected into the lower third of the esophageal wall in 10 sites between 2 and 10 cm above the squamo-columnar junction. The control arm will receive no injection after the EEUS and upper GI endoscopy (sham procedure).
Clinical response will be assessed based on the evolution of the Eckardt score, a quality of life score (Gastrointestinal Quality of Life Index (GIQLI), and weight gain. A significant clinical response will be defined as an Eckardt score \< 3 (together with individual scores \< 2). Manometry patterns will be compared before and after the procedure. Safety will be monitored based on the occurrence of chest pain scored on a Likert scale and occurrence of adverse events.
Follow-up clinical evaluation will be performed 1 and 2 months after the procedure. A second esophageal HRM will be realized 3 months after the procedure, followed by endoscopic BTX injection in case of non-response and two monthly visits.
Follow-up visits will be done 6 and 12 months after the first procedure. An additional HRM will be performed at 12 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Botulinum toxin injection
Esophageal endoscopic injection of botulinum toxin
Esophageal endoscopic injection of botulinum toxin
Endoscopic injection of botulinum toxin in the esophageal muscle : one hundred units of type A botulinum toxin (Botox®, Allergan) diluted in 10 mL of normal saline and injected at the lower third of the esophageal wall in 10 sites between 2 and 10 cm above the Z-line.
No injection
No injection of botulinum toxin
No injection of botulinum toxin
Upper gastro-intestinal endoscopy without any injection
Interventions
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Esophageal endoscopic injection of botulinum toxin
Endoscopic injection of botulinum toxin in the esophageal muscle : one hundred units of type A botulinum toxin (Botox®, Allergan) diluted in 10 mL of normal saline and injected at the lower third of the esophageal wall in 10 sites between 2 and 10 cm above the Z-line.
No injection of botulinum toxin
Upper gastro-intestinal endoscopy without any injection
Eligibility Criteria
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Inclusion Criteria
* Man or woman 18-year old or older
* Normal upper gastrointestinal endoscopy within one year before inclusion
* Barium swallow without argument for external compression
* Effective form of birth control (if applicable)
* Signed written informed consent form voluntarily
* Patient with health insurance
Exclusion Criteria
* Past history of eso-gastric surgery
* Evolutive cancer or coagulation disorders
* Absence of effective form of birth control (if applicable)
* Pregnant woman or woman who plans to become pregnant during the expected length of the study
* Breastfeeding woman
* Allergy to botulinum toxin or excipients
* Myasthenia
* Aminoglycoside treatment
* Endoscopic contraindication prior to the study
* Endoscopic contraindication during the study
* Psychiatric or addictive disease which could affect compliance to the constraints of the study
* Patient refusing to participate to the study
* Language barrier limiting the understanding of the study
* Incapability to give consent
* Concomitant participation to another research study
* No written consent form
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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François MION, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Service d'Hépato-Gastro-Entérologie et Oncologie Digestive- Hôpital Haut Lévêque - CHU de Bordeaux
Bordeaux, , France
Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot Pavillon H 5 - Hospices Civils de Lyon
Lyon, , France
Countries
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References
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Mion F, Marjoux S, Subtil F, Pioche M, Rivory J, Roman S, Zerbib F. Botulinum toxin for the treatment of hypercontractile esophagus: Results of a double-blind randomized sham-controlled study. Neurogastroenterol Motil. 2019 May;31(5):e13587. doi: 10.1111/nmo.13587. Epub 2019 Apr 11.
Other Identifiers
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2012.779
Identifier Type: -
Identifier Source: org_study_id