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

A Prospective Randomized Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) as Treatment of Idiopathic Achalasia

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.

Study Overview

• Status: Recruiting
• Conditions: Achalasia
• Intervention / Treatment: Procedure: PD; Procedure: POEM

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: A Moonen, MD
• Study Contact Backup: Name: Koen Bellens, MSc.; Phone Number: 016 34 19 43; Email: koen.bellens@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: A Moonen, MD
    • Principal Investigator: G Boeckxstaens, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PD; pneumodilation	Procedure: PD; pneumodilation
ACTIVE_COMPARATOR: POEM; peroral endoscopic myotomy	Procedure: POEM; peroral endoscopic myotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	The quality of life is determined using a general QoL questionnaire, namely the SF36 questionnaire. In addition, a more disease specific questionnaire, i.e. the EORTC QLQ-OES24 questionnaire, is filled out. These questionnaires have scored the QoL at fixed time points during follow-up (1 month, 3 months and yearly).	2 years
complication rate	Complications (perforation, bleeding, etc) occurring during or immediately following the procedure are recorded by the attending phycisian. In addition, gastroesophageal reflux is measured using 24h pHmetry after 3 months and 1 year. The number of patients with pathological acid exposure (>4.5% of time a pH<4) will be assessed. Endoscopy is performed after 1 year to detect esophagitis. Esophagitis rates and LA grades of esophagitis will be assessed.	2 years
need for retreetment	Retreatment is allowed in the pneumodilation group when symptoms recur, which is defined as an Eckardt score of > 3. Symptom scores are assessed after one month, three months and then yearly.	2 years

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (ESTIMATE): February 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: S55020