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

C

Catholic University (KU) of Leuven

Status

Enrolling

Conditions

Achalasia

Treatments

Procedure: POEM
Procedure: PD

Study type

Interventional

Funder types

Other

Identifiers

NCT01793922
S55020

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

PD
Active Comparator group
Description:
pneumodilation
Treatment:
Procedure: PD
POEM
Active Comparator group
Description:
peroral endoscopic myotomy
Treatment:
Procedure: POEM

Trial contacts and locations

1

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Central trial contact

Koen Bellens, MSc.; A Moonen, MD

Data sourced from clinicaltrials.gov

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