Reduction in Symptomatic Esophageal Stricture Formation
Condition: Esophageal Stenosis
MeSH terms: Esophageal Stenosis
Intervention: prednisone; placebo
Intervention description: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision.; 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision.
Intervention MeSH terms: Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      Complete endoscopic resection of early neoplastic Barrett's Esophagus (BE) is a curative
      procedure. However, a significant proportion of patients develop symptomatic esophageal
      strictures following Complete Barrett's Eradication (CBE), and this limits the technique,
      particularly for circumferential and longer segment disease. Oral steroid therapy may reduce
      stricture formation; thereby allowing CBE to be performed with minimal associated morbidity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed Barretts mucosa with high grade dysplasia or early esophageal
             adenocarcinoma (T1a, intramucosal adenocarcinoma).

          2. Barretts segment ≥ 30% circumference, ≤C3 and ≤M5.

          3. The general health condition of the patient permits anesthesia for endoscopy.

          4. Patient is 18 years of age or older.

          5. Informed consent is obtained

        Exclusion Criteria:

          1. Previous (referral) biopsies show low grade dysplasia only, or invasive
             adenocarcinoma.

          2. Barretts segment <30% circumference, >C3 or >M5.

          3. During initial gastroscopy there are highly suspicious areas for submucosal invasive
             cancer (Kudo pit pattern type V; excavated/depressed type morphology; large smooth or
             ulcerated nodule). In cases of significant doubt, initial resection is of the highly
             suspicious area only, and urgent histology processing requested. If submucosal
             invasion is excluded, the patient is rebooked for 1st stage complete barrett's
             excision (60% circumferential resection) and randomization after a 4-6 weeks interval.

          4. Presence of a tight peptic oesophageal stricture that impedes safe and effective
             endoscopic mucosal resection using a cap (Cook Medical).

          5. Active malignancy, uncontrolled Diabetes Mellitus, active or untreated major
             psychiatric disorder, uncontrolled infection, uncontrolled hypertension, uncontrolled
             or severe congestive cardiac failure, non-correctable coagulopathy (INR>2, or platelet
             count <60 x 109/L), osteoporosis, recent peptic ulcer disease, moderate-to-severe
             glaucoma or untreated glaucoma, or pregnancy.

          6. Unable to provide informed consent

          7. Allergy to compound used in tablet formulation