Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

Study Overview
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Brief Summary
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Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.

Detailed Description
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Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C). Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group). Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)

Official Title
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Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique

Conditions
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Esophageal Achalasia

Intervention / Treatment
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* Procedure: Water-jet POEM
* Procedure: Conventional POEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With an Eckardt symptom score ≥ 4 The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy) Informed patient consent was obtained Exclusion Criteria: Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk Pseudoachalasia Megaesophagus (diameter of > 7 cm)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Water-jet POEM<br>POEM were performed by the use of Erbe Hybrid knife (WJ group) | Procedure: Water-jet POEM<br>* Water-jet assisted POEM procedure was performed<br>|
| Active Comparator: Conventional POEM<br>POEM were performed by the conventional technique using injection and triangle tip knife (C group). | Procedure: Conventional POEM<br>* POEM were performed by the use of conventional technique using injection and triangle tip knife.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time in both groups |  | during POEM procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical efficacy and safety | bleeding complications, pneumothorax or pleural effusion requiring intervention | during hospital stay and up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Achalasia,, Peroral endoscopic myotomy,, Water-jet assisted