Actively Recruiting
Per Oral Endoscopic Myotomy and Prolonged Dilatation as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders
Led by Medical University of Vienna · Updated on 2015-08-10
400
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Achalasia is a disorder affecting the movement of the esophagus, causing symptoms like difficulty swallowing, regurgitation, chest pain, and weight loss. This research evaluates the long-term effectiveness of four different treatments for achalasia and related esophageal motility disorders. The study aims to compare newer endoscopic options with conventional treatments to find the best approaches for individualized care. The treatments being studied include Per Oral Endoscopic Myotomy (POEM), which is an endoscopic procedure to cut muscles in the esophagus; Prolonged Dilatation (PRD) involving the temporary placement of large stents fixed to the esophageal wall; conventional balloon dilatation; and laparoscopic Heller myotomy surgery. These interventions are performed as initial treatments and may also be options after previous treatments have failed. Participants will be monitored closely with evaluations including symptom scoring using the Eckardt score six months after treatment. Additional tests include measuring barium height in esophagograms, lower esophageal sphincter pressure, stent migration shortly after placement, and acid exposure in the esophagus. The study is non-randomized and does not involve masking. Follow-up and assessments will continue to ensure safety and measure treatment outcomes over time.
CONDITIONS
Brief Title
Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of achalasia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
- Age 18 years or older
You will not qualify if you...
- Contraindication for EGD (upper endoscopy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months post-operation
Participants undergo one of the following endoscopic or surgical procedures: per oral endoscopic myotomy, prolonged dilatation by implantation of large diameter stents, endoscopic balloon dilatation, or laparoscopic Heller myotomy.
1 treatment visit (procedure) and approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Department of Surgery, Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
D
Department of Surgery, Medical University of Vienna
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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