Reduction in Symptomatic Esophageal Stricture Formation

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Esophageal Stenosis

In brief

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.

Key facts

Study ID

NCT02039115

Run by

AdventHealth

People needed

3

Starts

2014-03-01

Expected to finish

2015-02-01

Last updated by the study team

2017-09-08

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed Barretts mucosa with high grade dysplasia or early esophageal adenocarcinoma (T1a, intramucosal adenocarcinoma).
• Barretts segment ≥ 30% circumference, ≤C3 and ≤M5.
• The general health condition of the patient permits anesthesia for endoscopy.
• Patient is 18 years of age or older.
• Informed consent is obtained

You may not qualify if…

• Previous (referral) biopsies show low grade dysplasia only, or invasive adenocarcinoma.
• Barretts segment <30% circumference, >C3 or >M5.
• 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.
• Presence of a tight peptic oesophageal stricture that impedes safe and effective endoscopic mucosal resection using a cap (Cook Medical).
• 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.
• Unable to provide informed consent
• Allergy to compound used in tablet formulation

Where it is running

• Florida Hospital — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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