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

NCT01793922 | Completed DMC

• 1 other identifier: S55020
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

• therapeutic succes

  The time till failure is the primary outcome parameter. The time is measured from date of pneumatic dilation (last session) or POEM to date of relapse of symptoms (date of establishment). Symptoms will be evaluated using the Eckardt scoring system (Table 1.). Therapeutic success is defined as a drop in Eckardt score to ≤ 3 after treatment and symptom control at yearly follow-up which is also defined as an Eckardt score of ≤ 3. If symptoms recur within patients randomized for pneumatic dilation, retreatment with pneumatic dilation is allowed according to the protocol. If retreatment does not result in reduction of the symptom score below 4, the patient will be considered as a treatment failure.

  2 years

Secondary Outcomes (3)

• quality of life after 1 month, 3 months and every year

  2 years

• complication rate

  2 years

• need for retreetment

  2 years

Study Arms (2)

PD

ACTIVE COMPARATOR

pneumodilation

Procedure: PD

POEM

ACTIVE COMPARATOR

peroral endoscopic myotomy

Procedure: POEM

Interventions

PD PROCEDURE

pneumodilation

PD

POEM PROCEDURE

peroral endoscopic myotomy

POEM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: February 18, 2013
• Study Start: October 1, 2013
• Primary Completion: June 21, 2021
• Study Completion: February 18, 2022
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

BE (1)