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Completed

NCT Number: NCT01942018

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

POEM

Procedure

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

Primary outcomes

  1. Change in dysphagia severity

    Time frame: 2 and 6 months

    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)

Secondary outcomes

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

    Time frame: 2 months

  2. Change in participants' quality of life

    Time frame: 2 and 6 months

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

  3. Complication rate

    Time frame: 2 years

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

  4. Length of hospital stay

    Time frame: 2 years

  5. Procedural times

    Time frame: 2 years

  6. Post procedural Gastroesophageal reflux disease (GERD)

    Time frame: 2 months

    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

  7. Time to resume normal diet

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2013
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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