Assessment of Different Modified POEM for Achalasia
Comparison Study of Conventional Peroral Endoscopic Myotomy (POEM) and Different Modified Procedures of POEM for Achalasia
Peking Union Medical College Hospital
52 participants
Sep 2, 2020
INTERVENTIONAL
Conditions
Summary
The aims of this study is to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of achalasia patients.
Eligibility
Inclusion Criteria3
- diagnosed as achalasia type I or II according to the Chicago Classification Version 4.0, with an Eckardt score >3
- Their age is ≥14years and ≤70 years
- Able to give written consent
Exclusion Criteria8
- undergone previous surgical treatments
- had contra-indication to general anesthesia
- previous surgery of the mediastinum, stomach, or esophagus;
- Pregnant or lactating female
- type III achalasia
- current alcohol or drug addiction, mental retardation, severe congenital or acquired coagulopathy (international normalized ratio >1.6)
- hepatic cirrhosis with or without portal hypertension, eosinophilic esophagitis (biopsies were performed at index endoscopy), or confirmed Barrett's esophagus
- esophageal diverticula or hiatal hernia based on findings from the index barium esophagram, or other conditions that the investigator believed not appropriate for POEM procedure
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ. 3. Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 2 cm distal to the GEJ. 4. Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.
1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ. 3. Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 4 cm proximal to the GEJ, and a full-thickness muscle myotomy is continually carried out from 4cm proximal to the GEJ down to 2 cm distal to the GEJ. 4. Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04578769