RecruitingNot ApplicableNCT02518542

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


Sponsor

Medical University of Vienna

Enrollment

400 participants

Start Date

Jun 1, 2014

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm

Exclusion Criteria1

  • Contraindication for EGD

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREEndoscopic intervention A

POEM: Per oral endoscopic myotomy

PROCEDUREEndoscopic intervention B

PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.

PROCEDUREEndoscopic intervention C

Endoscopic balloon dilatation

PROCEDURELaparoscopic Surgery

Laparoscopic Heller myotomy


Locations(1)

Department of Surgery, Medical University of Vienna

Vienna, Austria

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02518542


Related Trials