NCT04096703 - Idiopathic Esophagogastric Junction Outflow Obstruction | Crick

Overview

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

The objectives of this study are to address these gaps in knowledge by: Performing a randomized controlled trial in patients with idiopathic EGJOO that compares treatment outcomes after pneumatic dilation versus expectant management (disease controls) (expectant management). And, determining rational physiological and objective measures of treatment response.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Esophagogastric Junction Disorder

Interventions

Pneumatic dilationPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 6

Number of participants with retained barium column ≥5cm

Measured in the timed barium esophagram