Nutcracker Oesophagus Clinical Trial
Official title:
Endoscopic Injection of Botulinum Toxin in Patients With Hypercontractile Esophageal Motility Disorders: a Prospective, Randomized, Double-blind, Controlled Study
This study aims to evaluate the efficacy and the safety of endoscopic injection of 100 IU of botulinum toxin (BTX) in the distal esophagus in patients with symptoms related to hypercontractile esophageal motility disorders.
Eligible patients will present chest pain and/or dysphagia related to the following
hypercontractile esophageal motility disorders: distal esophageal spasm, jackhammer
esophagus, nutcracker esophagus or type III achalasia with normalization of the integrated
relaxation pressure after treatment, based on the Chicago classification of esophageal
motility disorders for high resolution manometry (HRM). Upper gastrointestinal endoscopy and
barium swallow will be performed before BTX injection to eliminate secondary disorders.
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.
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