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

Launched by KU LEUVEN · Feb 14, 2013

Keywords

ClinConnect Summary

The POEM Trial is a study designed to compare two treatments for a condition called achalasia, which makes it difficult for food to move from the esophagus to the stomach. The trial is looking at the effectiveness of a procedure called per-oral endoscopic myotomy (POEM) versus another treatment known as pneumodilation, to see which one works better for patients who have not received treatment before. Researchers believe that POEM may provide longer-lasting relief from symptoms compared to pneumodilation.

To participate in this trial, individuals must be between 18 and 75 years old and have a confirmed diagnosis of achalasia, with a score indicating significant symptoms. Some people may not be eligible, including those with certain serious health conditions or previous surgeries on the esophagus or stomach. Participants will have the opportunity to receive one of the two treatments and will be monitored throughout the study to assess how well each treatment works. It's important for potential participants to understand the requirements and that their involvement will contribute to finding better treatments for achalasia in the future.

Gender

ALL

Eligibility criteria

• 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