Per Oral Endoscopic Myotomy (POEM) for Esophagogastric Junction Outflow Obstruction (EGOO)
Completed · Not applicable
Conditions studied: Esophagogastric Junction Outflow Obstruction
In brief
This research is being done to study an endoscopic procedure called "POEM" as a less invasive alternative to surgery in people with esophagogastric junction outlet obstruction (EGOO).
Key facts
- Study ID
- NCT01942018
- Run by
- Johns Hopkins University
- People needed
- 15
- Starts
- 2015-05-01
- Expected to finish
- 2020-05-01
- Last updated by the study team
- 2020-05-28
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Consecutive adult patients (18-70 years of age) with symptomatic dysphagia (dysphagia score ≥2) EGOO that is diagnosed by high resolution manometry.
- Ability to give informed consent.
You may not qualify if…
- Unable to give informed consent
- Pregnant or breastfeeding women (all female patients if child-bearing age will undergo urine pregnancy testing prior to endoscopy)
- Acute gastrointestinal bleeding
- Coagulopathy defined by prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 1.5), on chronic anticoagulation, or platelet count <75,000
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
- Prior esophageal or gastric surgeries
- Cirrhosis with portal hypertension, varices, and/or ascites
- Active Esophagitis
- Hiatal hernia larger than 2cm
- Barrett's esophagus
- Eosinophilic esophagitis
- Esophageal stricture
- Esophageal malignancy
- Large esophageal diverticulum
- Mechanical obstruction to esophageal outflow or infiltrative esophageal or gastric disorders.
- Prior esophageal Botox injection
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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