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

NCT ID: NCT01793922

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Achalasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD

pneumodilation

Group Type ACTIVE_COMPARATOR

PD

Intervention Type PROCEDURE

pneumodilation

POEM

peroral endoscopic myotomy

Group Type ACTIVE_COMPARATOR

POEM

Intervention Type PROCEDURE

peroral endoscopic myotomy

Interventions

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PD

pneumodilation

Intervention Type PROCEDURE

POEM

peroral endoscopic myotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Guy Boeckxstaens

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Koen Bellens, MSc.

Role: CONTACT

016 34 19 43

A Moonen, MD

Role: CONTACT

Facility Contacts

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A Moonen, MD

Role: primary

Other Identifiers

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S55020

Identifier Type: -

Identifier Source: org_study_id

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