NCT02989883

Clinical Outcomes of Peroral Endoscopic Myotomy

Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Achalasia

Interventions

Type	Name	Description
OTHER	peroral endoscopic myotomy	The procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-03-01
• Completion: 2018-09-01
• First posted: 2016-12-12
• Last updated: 2016-12-12

Locations

1 site across 1 country: South Korea