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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Austria
Department of Surgery, Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Department of Surgery, Medical University of Vienna
sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at
+43 1 40400
Time Frame
Start Date: 2014-06
Estimated Completion Date: 2027-06
Participants
Target number of participants: 400
Treatments
Active_comparator: Per oral endoscopic therapy A
Per oral endoscopic myotomy
Active_comparator: Per oral endoscopic therapy B
Prolonged dilatation by implantation of large diameter stents.
Active_comparator: Per oral endoscopic therapy C
Dilatation
Active_comparator: Laparoscopic surgery
Laparoscopic Heller myotomy
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov