Idiopathic Esophagogastric Junction Outflow Obstruction

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Esophagogastric Junction Disorder

Treatments: Procedure: Pneumatic dilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04096703

IRB00060689

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Expectant management of EGJOO Group

No Intervention group

Description:

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 group

Description:

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

Treatment:

Procedure: Pneumatic dilation