The Chicago Classification of esophageal motility disorders, v3.0.
P J Kahrilas, A J Bredenoord, M Fox...
https://pubmed.ncbi.nlm.nih.gov/25469569Actively Recruiting
Phase Not Applicable
Age: 14Years - 70Years
All Genders
ID04578769
Comparison Study of Conventional Peroral Endoscopic Myotomy and Modified Full-Thickness Myotomy Procedures for 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
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Perioperative period
Participants undergo either conventional myotomy or full-thickness myotomy procedures to treat achalasia.
1 procedure visit (in-person) plus perioperative hospitalization
Follow-up
Duration - 6 months
Participants are monitored for therapeutic success, complications, and recovery for 6 months after the procedure.
Visits for assessments at 6 months after the procedure
Trial Site Locations
Total: 1 location
1
Department of Gastroenterology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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Research Team
T
Tao Guo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Statement for gastroesophageal reflux disease after peroral endoscopic myotomy from an international multicenter experience.
Haruhiro Inoue, Hironari Shiwaku, Yasutoshi Kobayashi...
https://pubmed.ncbi.nlm.nih.gov/31559513Clinical practice guidelines for peroral endoscopic myotomy.
Haruhiro Inoue, Hironari Shiwaku, Katsuhiko Iwakiri...
https://pubmed.ncbi.nlm.nih.gov/30022514Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study.
J Wang, N Tan, Y Xiao...
https://pubmed.ncbi.nlm.nih.gov/25214469Safety and efficacy of using a short tunnel versus a standard tunnel for peroral endoscopic myotomy for Ling type IIc and III achalasia: a retrospective study.
Longsong Li, Ningli Chai, Enqiang Linghu...
https://pubmed.ncbi.nlm.nih.gov/30187204Myotomy length informed by high-resolution esophageal manometry (HREM) results in improved per-oral endoscopic myotomy (POEM) outcomes for type III achalasia.
Erica D Kane, Vikram Budhraja, David J Desilets...
https://pubmed.ncbi.nlm.nih.gov/30054739Full-thickness myotomy is associated with higher rate of postoperative gastroesophageal reflux disease.
Xue-Hong Wang, Yu-Yong Tan, Hong-Yi Zhu...
https://pubmed.ncbi.nlm.nih.gov/27895430Peroral endoscopic myotomy for the treatment of achalasia: a clinical comparative study of endoscopic full-thickness and circular muscle myotomy.
Quan-Lin Li, Wei-Feng Chen, Ping-Hong Zhou...
https://pubmed.ncbi.nlm.nih.gov/23891074