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

NCT ID: NCT01942018

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2020-05-31

Brief 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).

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.

Conditions

Esophagogastric Junction Outflow Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EGOO

Patients presenting with symptomatic gastroesophageal junction outflow obstruction (EGOO)who will be treated with Per oral endoscopic myotomy (POEM)

Group Type: EXPERIMENTAL

POEM

Intervention Type: PROCEDURE

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

Interventions

POEM

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mouen A Khashab, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00082967

Identifier Type: -

Identifier Source: org_study_id