CompletedNot Applicable

Per Oral Endoscopic Myotomy (POEM) for Esophagogastric Junction Outflow Obstruction (EGOO)

United States15 participantsStarted 2015-05

Plain-language summary

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).

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Change in dysphagia severity

Timeframe: 2 and 6 months

Trial details

NCT IDNCT01942018

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04

View on ClinicalTrials.gov More Esophagogastric Junction Outflow Obstruction trials