Reduction in Symptomatic Esophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy
Conditions
Esophageal Stenosis
Conditions: official terms
Adenocarcinoma - Esophageal Stenosis
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Intervention
Name: prednisone Type: Drug
Name: placebo Type: Drug
Overall Status
Recruiting
Summary
Complete endoscopic resection of early neoplastic BE is a curative procedure. However, a significant proportion of patients develop symptomatic esophageal strictures following 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.
Detailed Description
The main objective of the proposed randomized trial is to compare the rate of symptomatic oesophageal strictures in patients receiving placebo versus oral prednisone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 89 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Histologically confirmed Barretts mucosa with HGD or early EAC (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 CBE (60% circumferential resection) and randomization after a 4-6 weeks interval.

4. Presence of a tight peptic oesophageal stricture that impedes safe and effective EMR using the DuetteTM 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
Location
Florida Hospital
Orlando, Florida, United States
Status: Recruiting
Contact: Amy Logue, MSN - 407-303-9736 - amy.logue@flhosp.org
Start Date
March 2014
Completion Date
December 2015
Sponsors
Florida Hospital
Source
Florida Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page