POEM vs. Pneumatic Dilation for Esophageal Achalasia

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of peroral endoscopic myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.

Clinical Trial Description

Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.

Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.

Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.

However, the long-term efficacy and safety of POEM were not determined, and there was no prospective study that compared the POEM with other conventional treatment. Therefore, we aim to determine the efficacy and safety of POEM, compared with the pneumatic dilation, in the treatment of esophageal achalasia. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Esophageal Achalasia

Clinical Trial Details

NCT number	NCT01768091
Study type	Interventional
Source	Nanfang Hospital of Southern Medical University
Contact	Wei Gong, M.D.
Phone	+86 15820290385
Email	gwei203@yahoo.com.cn
Status	Recruiting
Phase	N/A
Start date	December 2011
Completion date	December 2013

View Details

See also
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Active, not recruiting	`NCT00188344` - A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia	N/A
Recruiting	`NCT04578769` - Assessment of Different Modified POEM for Achalasia	N/A
Not yet recruiting	`NCT05010889` - Quality of Life After POEM for Achalasia
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Active, not recruiting	`NCT01750385` - Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia	N/A
Active, not recruiting	`NCT03404739` - Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia	Phase 2/Phase 3
Completed	`NCT04112693` - Assessment of the Neuro-glio-epithelial Unit (NGEU) in Biopsies Taken During Peroral Endoscopic Myotomy (POEM) for Achalasia: a Feasibility and Safety Study.	N/A
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Recruiting	`NCT05113173` - Study on the Relationship Between Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy
Completed	`NCT02999451` - Snare-assisted POEM for Treatment of Esophageal Achalasia	N/A
Completed	`NCT00490750` - Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia	N/A
Recruiting	`NCT02518542` - Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia	N/A
Recruiting	`NCT00260585` - Esophageal Cancer Risk Registry
Recruiting	`NCT05899842` - Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia	N/A
Completed	`NCT03702647` - Ropivacaine For Post-POEM Pain Control	N/A
Recruiting	`NCT01637311` - Peroral Endoscopic Remyotomy for Failed Heller Myotomy	N/A
Completed	`NCT00004416` - Randomized Study of Botulinum Toxin Type A for Achalasia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.