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Idiopathic Esophagogastric Junction Outflow Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096703
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Esophagogastric Junction Disorder Procedure: Pneumatic dilation Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of Lower Esophageal Sphincter Function in Idiopathic Esophagogastric Junction Outflow Obstruction and Clinical Response to Pneumatic Dilation
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Arm Intervention/treatment
No Intervention: Expectant management of EGJOO Group
The participants randomized to this group will receive expectant management of EGJOO. Expectant management is evaluating whether symptoms improve over time without an intervention
Experimental: Pneumatic dilation of EGJOO Group
The participants randomized to the pneumatic dilation cohort will undergo an initial pneumatic dilation with a 30mm Rigiflex (Boston Scientific).
Procedure: Pneumatic dilation
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).




Primary Outcome Measures :
  1. Brief esophageal dysphagia questionnaire (BEDQ) [ Time Frame: Week 0 ]
    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.

  2. Brief esophageal dysphagia questionnaire (BEDQ) [ Time Frame: 6 months ]
    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.

  3. Eckardt Score [ Time Frame: Week 0 ]
    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.

  4. Eckardt Score [ Time Frame: Week 4 ]
    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.

  5. Eckardt Score [ Time Frame: Week 6 ]
    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.

  6. Number of participants with retained barium column ≥5cm [ Time Frame: Week 6 ]
    Measured in the timed barium esophagram



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096703


Contacts
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Contact: Nicole Rojas 336-713-5026 nrojas@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Steven Clayton, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04096703    
Other Study ID Numbers: IRB00060689
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Idiopathic Esophagogastric Junction Outflow Obstruction
Esophageal Sphincter Function
Esophagogastric Junction
Pneumatic Dilation