A prospective randomized multi-center study comparing endoscopic pneumodilation and per oral endoscopic myotomy (POEM) as treatment of idiopathic achalasia

Recruiting

• Conditions: dysfagie; idiopatic achalasie; sphincter into the esophagus; 10018008

• Registration Number: NL-OMON53016
• Lead Sponsor: niversity Hospital Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Between 18 and 75 year of age
- Manometric diagnosis of achalasia
- Eckardt score >3
- signed Informed consent

Exclusion Criteria

- Severe cardio-pulmonary disease or other serious disease leading to
unacceptable surgical risk.
- Previous treatment, except treatment with nitroderivatives, Ca++ channel
blockers or sildenafil, or dilation with Savary bougies or balloons of 2 cm
diameter or smaller
- Pseudo-achalasia
- Mega-esophageal (> 7 cm) and/or sigmoid-like esophagus
-Previous esophageal or gastric surgery (except for gastric perforation)
- Not capable to fill out questionnaires (e.g. due to language barrier)
- Not available for follow-up
- Esophageal diverticula in the distal esophagus
- Malignant or premalignant esophageal lesions
- Patients with liver cirrhosis and/or esophageal varices
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified