Status:
TERMINATED
Endoscopic Peroral Myotomy for Treatment of Achalasia
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Achalasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.
Detailed Description
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s 70 patients will be enrolled to evaluate feasib...
Eligibility Criteria
Inclusion
- Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy which are consistent with the diagnosis
- persons of age \> 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
- Signed written informed consent.
Exclusion
- Patients with previous surgery of the stomach or esophagus
- Patients with known coagulopathy
- Previous achalasia-treatment with surgery
- Patients with liver cirrhosis and/or esophageal varices
- Active esophagitis
- Eosinophilic esophagitis
- Barrett's esophagus
- Pregnancy
- Stricture of the esophagus
- Malignant or premalignant esophageal lesion
- Candida esophagitis
- Hiatal hernia \> 2cm
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01405417
Start Date
April 1 2011
End Date
September 1 2017
Last Update
June 7 2019
Active Locations (5)
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1
Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
2
Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus
Frankfurt am Main, Germany, 60431
3
Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
Hamburg, Germany, 20246
4
Department of Gastroenterology and Hepatology, Academic Medical Center
Amsterdam, Netherlands, 1105 AZ