Status:
UNKNOWN
POEM Trial: Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM)
Lead Sponsor:
KU Leuven
Conditions:
Achalasia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It is hypothesized...
Eligibility Criteria
Inclusion
- Between 18 and 75 yr of age
- Manometric diagnosis of achalasia
- Eckardt score \> 3
- Informed consent
Exclusion
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk previous treatment, except treatment with nitroderivatives, Ca++ channel blockers or sildenafil, or dilation with Savary bougies or balloons of 2 cm diameter or smaller.
- Pseudo-achalasia Mega-esophagus (\> 7 cm) and/or sigmoid-like esophagus Previous esophageal or gastric surgery (except for gastric perforation) Not capable to fill out questionnaires (f.e. due to language barrier) Not available for follow-up Esophageal diverticula in the distal esophagus Malignant or premalignant esophageal lesions Patients with liver cirrhosis and/or esophageal varices Pregnancy
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01793922
Start Date
October 1 2013
End Date
January 1 2025
Last Update
February 8 2023
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000