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RECRUITING
NCT02518542
NA

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

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2014-06

Completion Date

2027-06

Last Updated

2015-08-10

Healthy Volunteers

No

Interventions

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

Locations (1)

Department of Surgery, Medical University of Vienna

Vienna, Austria