CompletedNot Applicable

POEM Trial: Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM)

Belgium132 participantsStarted 2013-10

Plain-language 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 that POEM has a higher long-term efficacy than pneumodilation in treatment of therapy-naive patients with idiopathic achalasia.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between 18 and 75 yr of age * Manometric diagnosis of achalasia * Eckardt score \> 3 * Informed consent Exclusion Criteria: * 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

What they're measuring

therapeutic succes

Timeframe: 2 years

Trial details

NCT IDNCT01793922

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-21

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