Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID02518542

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of achalasia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Contraindication for EGD (upper endoscopy)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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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