Status:
COMPLETED
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 single center setting in Europe.
Detailed Description
This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe. 16 patients are enrolle...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy 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 criteria:
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01405469
Start Date
November 1 2010
End Date
November 1 2016
Last Update
October 15 2019
Active Locations (1)
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1
Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
Hamburg, Germany, 20246