Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy

Esophageal stricture (ES) formation is a widely recognized adverse event of radical EMR and
ESD. Indeed, ES is the most common complication of radiofrequency ablation (RFA) for
Barrett's esophagus (BE), with a reported incidence ranging from 5% to 12%. A single-center
retrospective study reported ES formation in 67% of 73 patients with EMR of at least 50% of
their esophageal circumference. Similarly, the incidence of ES development after ESD is
between 70-90% when the mucosal defect involves more than three-quarters of the esophageal
circumference. In aggregate, the extent of the esophageal mucosal defect following
endotherapy appears to be the most consistent predictor of ES formation. Prevention of ES
development following endotherapy can significantly improve a patient's quality of life and
possibly reduce the potential risks and costs associated with treatment of ES with repeated
endoscopic balloon dilations (EBD). Glucocorticoids have been evaluated as a potential
preventive therapy for ES based on their anti-inflammatory properties and inhibitory effects
on collagen deposition. Oral prednisolone has been shown to be effective as a preventive
strategy for ES formation. However, prolonged use of systemic oral steroids can be associated
with multiple adverse effects.

Budesonide is a synthetic steroid with topical anti-inflammatory properties and high
first-pass metabolism; thus, potentially less systemic absorption and side effects. Most
recently Mayo Clinic Rochester developed a new budesonide capsule formulation. Alike viscous
budesonide the budesonide capsule can be opened and the powder can be mixed with honey or
pancake syrup. A similar formulation is currently used in pilot studies for treatment of
eosinophilic esophagitis. The advantage of budesonide capsule is the improve taste in
comparison to viscous budesonide originating from budesonide respules which is unpalatable.

Study aims:

1. The aim of this study is to prospectively record our experience with budesonide for the
prevention of esophageal stricture formation after endotherapy (mucosal resection,
submucosal dissection) as part of routine medical care.

2. The data will be compared with outcomes with well-annotated historical controls that
underwent similar procedure with similar follow up but without budesonide exposure.

3. If sufficient efficacy is seen, these data will be used to plan a prospective controlled
clinical trial. All patients in the study group will receive standard medical care and
no experimental interventions will be performed.

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