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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 14Years - 70Years
All Genders
ID04578769

Comparing Conventional and Full-Thickness Peroral Endoscopic Myotomy for Treating Esophageal Achalasia

Led by Peking Union Medical College Hospital · Updated on 2025-12-10

52

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness and safety of two different peroral endoscopic myotomy POEM techniques in treating patients with achalasia types I and II. The study focuses on conventional myotomy, which involves cutting only the inner circular muscle layer, and a modified approach called full-thickness myotomy, which includes cutting the full thickness of the muscle bundle. The goal is to determine which method better improves symptoms and reduces complications for achalasia patients. Participants will receive one of two procedures conventional myotomy or full-thickness myotomy. Both procedures start with a mucosal incision and creation of a submucosal tunnel near the gastroesophageal junction. The conventional method cuts only the circular muscle, while the full-thickness method additionally cuts the full muscle layer near the junction. After myotomy, the mucosal incision is closed with clips. The study compares these techniques by randomly assigning participants to one of the two groups. During the study, participants will be closely monitored before, during, and after the procedure. Researchers will measure therapeutic success at six months following treatment, along with procedure time, pressure changes in the esophagus, esophagogram results, complication rates, severity of esophagitis, and pain after POEM. Other assessments include endoscopic scoring and hospitalization duration. These evaluations will help determine the safety and benefits of each myotomy approach over a six-month period.

CONDITIONS

Brief Title

Assessment of Different Modified POEM for Achalasia

Who Can Participate

Age: 14Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with achalasia type I or II according to Chicago Classification Version 4.0 with an Eckardt score greater than 3
  • Age between 14 and 70 years
  • Able to provide written consent
Not Eligible

You will not qualify if you...

  • Previous surgical treatments for achalasia
  • Contraindications to general anesthesia
  • Prior surgery of the mediastinum, stomach, or esophagus
  • Pregnant or breastfeeding female
  • Diagnosed with type III achalasia
  • Current alcohol or drug addiction, mental retardation, severe congenital or acquired coagulopathy (INR >1.6)
  • Hepatic cirrhosis with or without portal hypertension, eosinophilic esophagitis, or confirmed Barrett's esophagus
  • Esophageal diverticula or hiatal hernia or other conditions deemed inappropriate for POEM by the investigator

Research Team

T

Tao Guo, MD

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