Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy

NCT02069847 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 13-009467
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Stricture

Keywords

Esophageal stricture formation; Endoscopic mucosal resection; Endoscopic submucosal dissection; Budesonide; Radical endoscopic mucosal resection; EMR; ESD

Outcome Measures

Primary Outcomes (1)

• Dysplasia in Barrett Esophagus (BE)

  Number of subjects with Non-dysplastic, low grade dysplasia, high grade dysplasia and T1a early esophageal adenocarcinoma. As measured by using the BE dysplasia grading system of Non-dysplastic (no cancerous tissue present), low-grade dysplasia (minor cell changes found), high-grade dysplasia (extensive cell changes found, but not yet cancer), and noninvasive cancer (T1a early esophageal adenocarcinoma)

  3 months

Secondary Outcomes (1)

• Rate of Esophageal Stricture

  3 months

Study Arms (2)

Esophageal stricture, Budesonide

EXPERIMENTAL

Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)

Drug: Budesonide

Control group

NO INTERVENTION

Retrospective collect data for subjects who undergo endoscopic submucosal dissection or endoscopic mucosal resection

Interventions

Budesonide DRUG

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.

Also known as: Budesonide, Entocort, Uceris

Esophageal stricture, Budesonide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Esophageal Stenosis

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Michael B. Wallace
• Organization: Mayo Clinic

wallace.michael@mayo.edu

507-953-2221

Study Officials

• Michael Wallace, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 24, 2014
• Study Start: February 1, 2014
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-05

Locations

US (1)