Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy

Completed · Phase 2

Conditions studied: Esophageal Stricture

In brief

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.

Key facts

Study ID

NCT02069847

Run by

Mayo Clinic

People needed

90

Starts

2014-02-01

Expected to finish

2019-01-11

Last updated by the study team

2020-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Diagnosis of esophageal lesion treated with ESD or EMR which involves ≥ 50% of the esophageal circumference.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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