Reduction in Symptomatic Esophageal Stricture Formation

NCT ID: NCT02039115

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-02-28

Brief 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.

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.

Conditions

Esophageal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

prednisone

Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision.

Group Type: EXPERIMENTAL

prednisone

Intervention Type: DRUG

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

placebo

Placebo tablets will be taken in the same manner as the prednisone arm.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

Interventions

prednisone

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

steroid; control

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Hawes Hawes, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

Florida Hospital

Orlando, Florida, United States

Countries

United States

Other Identifiers

461672

Identifier Type: -

Identifier Source: org_study_id