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

N/ACompletedNCT01942018

Johns Hopkins University15 enrolled

Overview

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).

Patients with EGOO have difficulty swallowing and/or chest pain. Previously we were not able to distinguish this disease from achalasia. Achalasia is a disease which is characterized by a progressive difficulty with swallowing. It is caused by failure of relaxation of the lower esophageal sphincter (sphincter between esophagus and stomach) along with an essentially aperistaltic esophageal body. However, EGOO patients have abnormal lower esophageal sphincter relaxation with some preserved peristaltic activity. Because they have some peristalsis, these patients are not diagnosed with achalasia. Currently, a new diagnostic method, known as high-resolution manometry (HRM), can identify EGOO patients. EGOO patients usually do not respond well to medical treatment and surgery is required in most cases to reduce the pressure of lower esophageal sphincter muscles. This procedure is called "Heller myotomy". Recently, a new endoscopic method for reducing lower esophageal sphincter pressure has been developed. This method, per-oral endoscopic myotomy (POEM) is now being performed clinically throughout the world, including Johns Hopkins Hospital. The technique utilizes a flexible endoscope to tunnel beneath the esophageal surface layer and cutting muscle fibers of the lower esophagus and upper stomach. POEM is an alternative to invasive surgery with fewer complications. POEM is performed safely at Johns Hopkins Hospital for achalasia patients. Outcomes of POEM have been excellent with greater than 90% positively responding to endoscopic myotomy. Patients with EGOO are being diagnosed more often due to increased use of HRM. They respond poorly to endoscopic therapies but well to surgical myotomy. POEM is the endoscopic equivalent to surgical intervention and represents a less invasive approach to treating these patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophagogastric Junction Outflow Obstruction

Interventions

POEMPROCEDURE

Patients will receive Per oral endoscopic myotomy (POEM) for symptomatic gastroesophageal junction outflow obstruction (EGOO)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Consecutive adult patients (18-70 years of age) with symptomatic dysphagia (dysphagia score ≥2) EGOO that is diagnosed by high resolution manometry. 2. Ability to give informed consent. Exclusion Criteria: 1. Unable to give informed consent 2. Pregnant or breastfeeding women (all female patients if child-bearing age will undergo urine pregnancy testing prior to endoscopy) 3. Acute gastrointestinal bleeding 4. 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 5. Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy 6. Prior esophageal or gastric surgeries 7. Cirrhosis with portal hypertension, varices, and/or ascites 8. Active Esophagitis 9. Hiatal hernia larger than 2cm 10. Barrett's esophagus 11. Eosinophilic esophagitis 12. Esophageal stricture 13. Esophageal malignancy 14. Large esophageal diverticulum 15. Mechanical obstruction to esophageal outflow or infiltrative esophageal or gastric disorders. 16. Prior esophageal Botox injection

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Change in dysphagia severity

Dysphagia will be measured by Dysphagia score and Eckhardt score at 2 and 6 months after the procedure (The Eckhardt score takes into consideration symptoms of dysphagia, chest pain, regurgitation and chest pain)

Time frame: 2 and 6 months

Secondary Outcomes

Resolution in Esophago-gastric junction (EGJ) outflow obstruction by HRM performed 2 months after the procedure

Time frame: 2 months

Change in participants' quality of life

Improvement in patient's quality of life as reflected by Short Form-36 questionnaire at 2 and 6 months after the procedure

Time frame: 2 and 6 months

Complication rate

Complications include any of the following (full thickness perforations, unplanned mucosectomies, immediate and delayed bleeding).

Time frame: 2 years

Length of hospital stay

Time frame: 2 years

Procedural times

Time frame: 2 years

Post procedural Gastroesophageal reflux disease (GERD)

Frequency of post-procedural GERD as documented by either 24 hr ph/Impedence testing, 48 hr Bravo (performed at 2 months), or esophagogastroduodenoscopy (EGD) with evidence of esophagitis

Time frame: 2 months

Time to resume normal diet

Time frame: 2 years

Data from ClinicalTrials.gov

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