Idiopathic Esophagogastric Junction Outflow Obstruction

NCT04096703 | Withdrawn

• 1 other identifier: IRB00060689
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two treatments for Idiopathic Esophagogastric Junction Outflow Obstruction: pneumatic dilation compared with expectant management, on symptoms and liquid barium emptying exams.

Conditions

Esophagogastric Junction Disorder

Keywords

Idiopathic Esophagogastric Junction Outflow Obstruction; Esophageal Sphincter Function; Esophagogastric Junction; Pneumatic Dilation

Outcome Measures

Primary Outcomes (6)

• Brief esophageal dysphagia questionnaire (BEDQ)

  The BEDQ is a 10-item self-report measure of dysphagia symptoms. The questionnaire is scored on a scale of 0-40. Higher scores indicate greater severity and frequency of dysphagia symptoms.

  Week 0

• Brief esophageal dysphagia questionnaire (BEDQ)

  The BEDQ is a 10-item self-report measure of dysphagia symptoms. The questionnaire is scored on a scale of 0-40. Higher scores indicate greater severity and frequency of dysphagia symptoms.

  6 months

• Eckardt Score

  The Eckardt score is the grading system most frequently used for the evaluation of symptoms and efficacy of achalasia treatment. 33 It attributes points (0-3 points) to 4 symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss), and its total ranges from 0-12. The higher the score the worse the symptoms.

  Week 0

• Eckardt Score

  The Eckardt score is the grading system most frequently used for the evaluation of symptoms and efficacy of achalasia treatment. 33 It attributes points (0-3 points) to 4 symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss), and its total ranges from 0-12. The higher the score the worse the symptoms.

  Week 4

• Eckardt Score

  The Eckardt score is the grading system most frequently used for the evaluation of symptoms and efficacy of achalasia treatment. 33 It attributes points (0-3 points) to 4 symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss), and its total ranges from 0-12. The higher the score the worse the symptoms.

  Week 6

• Number of participants with retained barium column ≥5cm

  Measured in the timed barium esophagram

  Week 6

Study Arms (2)

Expectant management of EGJOO Group

NO INTERVENTION

The participants randomized to this group will receive expectant management of EGJOO. Expectant management is evaluating whether symptoms improve over time without an intervention

Pneumatic dilation of EGJOO Group

EXPERIMENTAL

The participants randomized to the pneumatic dilation cohort will undergo an initial pneumatic dilation with a 30mm Rigiflex (Boston Scientific).

Procedure: Pneumatic dilation

Interventions

Pneumatic dilation PROCEDURE

The patients randomized to the pneumatic dilation cohort will undergo an initial pneumatic dilation with a 30mm Rigiflex (Boston Scientific). If the Eckardt score four weeks after initial dilation is \> 4, then the patient will be scheduled for a second dilation with a 35mm Rigiflex balloon (Boston Scientific).

Pneumatic dilation of EGJOO Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Initial HRIM consistent with the diagnosis of EGJOO and mechanical esophageal obstruction has been excluded by prior upper endoscopy.
• EGJOO patients with a retained liquid barium column on TBE ≥5cm in height at 1 minute
• Patients must have symptomatic dysphagia

You may not qualify if:

• Diseases that potentially could cause mechanical obstruction such as gastroesophageal reflux disease with erosive esophagitis, peptic stricture, cancer, eosinophilic esophagitis, prior fundoplication, adjustable gastric band surgery and hiatal hernias. Patients with any identifiable anatomic esophageal or gastric obstruction will be excluded from the study
• Patients with previous surgery on the esophagus or stomach
• Previous history of per oral endoscopic myotomy or prior pneumatic dilation
• History of gastroparesis

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Steven Clayton, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: October 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 4, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)