NCT02518542

Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia

Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss. Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy. Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM. The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.

Conditions

• Esophageal Achalasia

Interventions

Type	Name	Description
PROCEDURE	Endoscopic intervention A	POEM: Per oral endoscopic myotomy
PROCEDURE	Endoscopic intervention B	PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
PROCEDURE	Endoscopic intervention C	Endoscopic balloon dilatation
PROCEDURE	Laparoscopic Surgery	Laparoscopic Heller myotomy

Timeline

• Start date: 2014-06-01
• Primary completion: 2024-06-01
• Completion: 2027-06-01
• First posted: 2015-08-10
• Last updated: 2015-08-10

Locations

1 site across 1 country: Austria