Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy

• Status: Completed
• Trial end date: 2019-01-11
• Target enrollment: 0
• Participant gender: All

Summary

Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and early esophageal cancers. However, esophagectomy is associated with significant morbidity and mortality. With the advance of therapeutic endoscopy, there has been a growing interest and application of endoscopic resection and mucosal ablative techniques for the treatment of these diseases. Esophageal stricture (ES) formation has become an increasingly recognized complication of extensive endoscopic mucosal ablation and/or resection. The resultant symptomatic stricture development can significantly impair a patient's quality of life. Endoscopic therapy of esophageal strictures with balloon dilation and/or local steroid injection is invasive, costly, and associated with the potential risk of perforation. Recently, oral corticosteroids have been introduced for the prevention of esophageal stricture after endoscopic submucosal dissection.

Budesonide is a synthetic steroid with topical anti-inflammatory properties and high first-pass metabolism; thus, potentially less systemic absorption and side effects.

Hypothesis: Oral budesonide prevents esophageal stricture formation in patients who underwent radical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for advanced premalignant esophageal lesions or superficial esophageal cancers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Age 18 years or older

• Diagnosis of esophageal lesion treated with ESD or EMR which involves ≥ 50% of the esophageal circumference.

Exclusion Criteria:

• Locally advanced disease

• Prior esophageal surgery

• Participation in another research protocol that could interfere or influence the outcome measures of the present study.

• The subject or legal representative is unable/unwilling to give informed consent. (study group)

• Medications or conditions for which there is a contraindication to use of budesonide (see pharmacology section below)

• Concomitant use of systemic steroids or other immune suppressive medication for a different condition 9. Pregnant women