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

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).

Study Overview

• Status: Completed
• Conditions: Esophagogastric Junction Outflow Obstruction
• Intervention / Treatment: Procedure: POEM

Detailed Description

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
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EGOO; Patients presenting with symptomatic gastroesophageal junction outflow obstruction (EGOO)who will be treated with Per oral endoscopic myotomy (POEM)	Procedure: POEM; Patients will receive Per oral endoscopic myotomy (POEM) for symptomatic gastroesophageal junction outflow obstruction (EGOO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		2 years
Resolution in Esophago-gastric junction (EGJ) outflow obstruction by HRM performed 2 months after the procedure		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	2 and 6 months
Complication rate	Complications include any of the following (full thickness perforations, unplanned mucosectomies, immediate and delayed bleeding).	2 years
Procedural times		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	2 months
Time to resume normal diet		2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: GERD; Gastroesophageal reflux disease; POEM; Per oral endoscopic myotomy; esophagogastric junction outflow obstruction; EGOO
• Other Study ID Numbers: NA_00082967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided