NCT04180241

Development of Endoscopic Treatment for Achalasia

Development of Endoscopic Treatment for Achalasia, POEM (Per Oral Esophageal Myotomy): A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.

Detailed description

Prior to surgery, all patients undergo upper endoscopy , x-ray "time barium" manometry, 24 hours pH registration. Moreover Quality of Life instrument (RAND-36), GSRS (Gastrointestinal Symptom Rating Scale) and a dysphagia score (Eckardt score) are completed by all patients. Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score). At 3,12 and 36 months an x-ray "time barium" is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.

Conditions

• Achalasia

Interventions

Type	Name	Description
PROCEDURE	POEM	Peroral endoscopic myotomy

Timeline

• Start date: 2019-04-15
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2019-11-27
• Last updated: 2024-05-08

Locations

2 sites across 1 country: Sweden