Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy
Status:
Completed
Trial end date:
2019-01-11
Target enrollment:
Participant gender:
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.