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

NCT01942018 | Completed DMC

• 1 other identifier: NA_00082967
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Esophagogastric Junction Outflow Obstruction

Keywords

esophagogastric junction outflow obstruction; EGOO; Per oral endoscopic myotomy; POEM; Gastroesophageal reflux disease; GERD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  2 months

• Change in participants' quality of life

  2 and 6 months

• Complication rate

  2 years

• Length of hospital stay

  2 years

• Procedural times

  2 years

Study Arms (1)

EGOO

EXPERIMENTAL

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

Procedure: POEM

Interventions

POEM PROCEDURE

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

EGOO

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mouen A Khashab, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 13, 2013
• Study Start: May 1, 2015
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

US (1)