POEM Anterior Versus Posterior Approach
Completed · Not applicable
Conditions studied: Achalasia
In brief
Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal achalasia, performed by GI endoscopist without cutting any surface of the human body. The main constituent of the procedure is the myotomy part, through which the endoscopist cuts the muscle fibers in the submucosa. Since this procedure is completely new to the area of treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be followed up for symptoms and complications; data will be extracted and the appropriate analysis will be employed to determine if there is any difference of outcome between the two techniques of myotomy.
Key facts
- Study ID
- NCT02454335
- Run by
- Johns Hopkins University
- People needed
- 150
- Starts
- 2015-01-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2018-01-02
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Previous surgery of the esophagus or stomach
- Active severe esophagitis
- Large lower esophageal diverticula
- Large > 3cm hiatal hernia
- Sigmoid esophagus
- Known gastroesophageal malignancy
- Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
- Cirrhosis with portal hypertension, varices, and/or ascites
- Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- Acute gastrointestinal bleeding
- Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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