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

Last updated: February 7, 2023
Sponsor: KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Achalasia

Treatment

N/A

Clinical Study ID

NCT01793922
S55020
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between 18 and 75 yr of age
  • Manometric diagnosis of achalasia
  • Eckardt score > 3
  • Informed consent

Exclusion

Exclusion Criteria:

  • Severe cardio-pulmonary disease or other serious disease leading to unacceptablesurgical risk previous treatment, except treatment with nitroderivatives, Ca++ channelblockers or sildenafil, or dilation with Savary bougies or balloons of 2 cm diameteror smaller. Pseudo-achalasia Mega-esophagus (> 7 cm) and/or sigmoid-like esophagus Previous esophagealor 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 thedistal esophagus Malignant or premalignant esophageal lesions Patients with liver cirrhosisand/or esophageal varices Pregnancy

Study Design

Total Participants: 150
Study Start date:
October 01, 2013
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.