Botulinum Toxin Injection in Hypercontractile Esophagus

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Botulinum Toxins

Criteria

Inclusion Criteria:

• Patient with non-cardiac chest pain and/or dysphagia with global Eckardt score strictly above 3 points or equal to 3 only for " chest pain " or " dysphagia " - Hypercontractile esophagus with normal esogastric junction relaxation based on the Chicago classification in high resolution manometry

• 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:

• Man or woman under 18-year old

• 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