Esophageal Spasm, Diffuse Clinical Trial
Official title:
Prospective Randomised Double-blind Sham Study on the Use of Botox for the Treatment of Diffuse Esophageal Spasm
This study evaluates the effect of botulinum toxin 100 U or saline, injected endoscopically in the distal esophagus, on symptoms and manometry pattern in patients with diffuse esophageal spasm.
Patients are selected on the basis of a clinical diagnosis of diffuse esophageal spasm,
based on endoscopy and manometry.
This is a sham-controlled cross-over study of injection of botulinum toxin or saline, in
randomized order, in the distal esophagus.
All patients have undergone esophageal manometry which shows diffuse esophageal spasm, and a
24h pH monitoring/manometry to quantify acid reflux. All drugs prescribed to affect
esophageal motility (nitrates, calcium antagonists) are stopped during the study. After
randomisation, the patient will undergo standard esophageal manometry to assess baseline
esophageal motility. On the same day the patient will be asked to fill out a set of symptom
questionnaires including a dysphagia questionnaire. At endoscopy, the active treatment group
receives 8 x 12.5 units, each in 0.5 ml, of botulinum toxin A which will be injected in the
four quadrants of the esophagus at 2 and 5 cm above the lower esophageal sphincter. In the
Sham group 8 * 0.5 ml of physiologic serum will be injected. The randomisation will be
performed at the endoscopy unit by a nurse otherwise not involved in the protocol.
After 1 month a stationary manometry and a new esophageal pH/manometry monitoring will be
performed, followed by a second endoscopy with injection of saline or botulinum toxin in a
cross-over mode. At the time of the second endoscopy each patient will fill out a dysphagia
questionnaire. One month later, the dysphagia questionnaire is repeated.
Subsequently, follow-up will occur at the outpatient clinic after 6 and 12 months, with
follow-up dysphagia questionnaires but no additional manometries or endoscopies, unless the
clinical status deteriorates.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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Peroral Endoscopic Myotomy Versus Botulinum Toxin Injection in Spastic Esophageal Disorders
|
N/A | |
| Recruiting |
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Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
|