Corticosteroids for Esophagogastric Junction Obstruction

Overseen By Daniel S Kim, MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Baylor Research Institute

Must be taking: Corticosteroids

Must not be taking: Immunosuppressants, Opioids

Disqualifiers: Foregut surgery, Hiatal hernia, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppression or immune modulating therapy, or if you have chronic opioid use.

Is steroid treatment generally safe for humans?

Steroid treatments, like prednisone, have been used safely in humans for various conditions, but they can have side effects such as pneumonia, oral herpes, candida infections, arthritis, and muscle weakness. These side effects were observed in studies involving esophageal procedures, but the treatments were generally considered safe when used with proper medical supervision. ^{1 2 3 4 5}

How does the drug differ from other treatments for esophagogastric junction obstruction?

Corticosteroids, like prednisone, are unique because they reduce inflammation and prevent scarring in the esophagus, which can help keep it open. This approach is different from other treatments that might focus on mechanically widening the esophagus or addressing symptoms without targeting inflammation. ^{1 5 6 7 8}

What is the purpose of this trial?

EGJOO is a disorder in which the muscles of the esophagus (swallowing tube) do not function in a coordinated fashion so that swallowed material does not pass easily into the stomach. EGJOO often causes symptoms of swallowing difficulties and chest pain. The cause of EGJOO and its optimal treatment are not clear. The investigators research team suspects that EGJOO might be caused by an allergy that involves the esophagus, and that treatment with medications called corticosteroids might improve function of the esophageal muscles. The purpose of this study is to learn how corticosteroid therapy affects the muscles of the esophagus in patients suffering with EGJOO.

Research Team

Chanakyaram Reddy, MD

Principal Investigator

Baylor Health Care System

Eligibility Criteria

This trial is for individuals with EGJOO, a condition where the esophagus muscles don't work well together, causing swallowing difficulties and chest pain. Participants must meet certain criteria not specified here.

Inclusion Criteria

Additional objective evidence of obstruction on Timed Barium Esophagram and/or EndoFLIP

I have difficulty swallowing and/or chest pain not related to heart issues.

My doctor recommends a specific procedure for my condition.

Exclusion Criteria

I cannot take oral corticosteroids due to health reasons.

I have had surgery on my upper digestive tract.

I am currently on medication that affects my immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 14-day course of oral, systemic corticosteroid therapy

2 weeks

1 visit (in-person) for esophageal manometry testing on the last day

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of Eckardt and BEDQ surveys

4 weeks

Treatment Details

Interventions

• Steroid treatment

Trial Overview The study tests if corticosteroids can improve esophageal muscle function in EGJOO patients. It involves steroid treatment, measuring muscle movement with esophageal manometry, and completing surveys about symptoms.

Participant Groups

Group I: Steroid Treatment Experimental Treatment 3 Interventions

All participants are in the treatment arm. Patients with Esophagogastric Junction Outflow Obstruction (EGJOO) will undergo steroid treatment for 14 days. On the last day of the 14 day treatment, patient will undergo esophageal manometry testing to assess for treatment response. They will also be asked to complete follow-up Eckardt and BEDQ surveys.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Efficacy of prednisone for prevention of esophageal stricture after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of modified oral steroid administration for preventing esophageal stricture after entire circumferential endoscopic submucosal dissection. [2022]

3. Egypt pubmed.ncbi.nlm.nih.gov

Feasibility of Short-Period, High-Dose Intravenous Methylprednisolone for Preventing Stricture after Endoscopic Submucosal Dissection for Esophageal Cancer: A Preliminary Study. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of short course oral prednisone for stricture prevention after semi-circumferential esophageal endoscopic submucosal dissection. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Systemic steroids have a role in treating esophageal strictures in pediatric eosinophilic esophagitis. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Efficacy of Oral Corticosteroids in Preventing Esophageal Stenosis after Large Area Endoscopic Submucosal Tunnel Dissection]. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of topical beclomethasone on inflammatory markers in adults with eosinophilic esophagitis: A pilot study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Eosinophilic esophagitis--pathogenesis, clinical presentation and therapeutic management]. [2021]