Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy
Condition: Esophageal Stricture
MeSH terms: Esophageal Stenosis; Constriction, Pathologic
Intervention: Budesonide
Intervention description: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply.
The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup.
Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide.
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esophageal stricture formation; Endoscopic mucosal resection; Endoscopic submucosal dissection; Budesonide; Radical endoscopic mucosal resection; EMR; ESD

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.
    

Eligibility 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