Reduction in Symptomatic Esophageal Stricture Formation

Esophageal Stenosis Clinical Trial

Official title:

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: A Randomized, Double-blinded, Placebo-controlled, Multicenter Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039115
• Other study ID #: 461672
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2014
• Last updated: February 13, 2017
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2017
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Stenosis

Intervention

Drug:
• prednisone
6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision.
• placebo
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.

Locations

Country	Name	City	State
United States	Florida Hospital	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stricture formation	Primary outcome measure is the rate of symptomatic esophageal stricture formation.	98 weeks