Clinical Outcomes of Peroral Endoscopic Myotomy

Not Applicable

• Conditions: Achalasia
• Interventions: Other: peroral endoscopic myotomy

• Registration Number: NCT02989883
• Lead Sponsor: Asan Medical Center

Brief Summary

Esophageal outflow obstruction is characterized by failure to relax the lower esophageal sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the LES and reduce its pressure to allow esophageal emptying. Therapeutic options include pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has recently been introduced as a minimally invasive treatment, but there have a few studies regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM for esophageal outflow obstruction.

Detailed Description

Prospective study

Study Timeline

• Study Start: 2016-10
• Status Verified: 2016-12
• Study First Submitted: 2016-12-04
• Study First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Study First Posted: 2016-12-12
• Last Update Posted: 2016-12-12
• Primary Completion: 2018-03
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients who were diagnosed as esophageal outflow obstruction
• Patients with informed consent

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Exclusion Criteria

• Diagnostic uncertainty
• Patients who are not suitable for general anesthesia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peroral endoscopic myotomy (POEM)	peroral endoscopic myotomy	Patients who received POEM

Primary Outcome Measures

Name	Time	Method
number of patients with Eckardt score <3 after the procedure	1 month after the procedure

Secondary Outcome Measures

Name	Time	Method
adverse events which are related to the procedure	within 30 days

Trial Locations

Locations (1)

Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of