Reduction in Symptomatic Esophageal Stricture Formation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02039115
Recruitment Status : Terminated (Closed for low enrollment and the inability to complete the study.)
First Posted : January 17, 2014
Results First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Information provided by (Responsible Party):
Florida Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Stenosis Drug: prednisone Drug: placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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.
Study Start Date : March 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: steroid

Placebo Comparator: placebo
Placebo tablets will be taken in the same manner as the prednisone arm.
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.
Other Name: control

Primary Outcome Measures :
  1. Stricture Formation [ Time Frame: 98 weeks ]
    Primary outcome measure is the rate of symptomatic esophageal stricture formation.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02039115

United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Sponsors and Collaborators
Florida Hospital
Principal Investigator: Robert Hawes Hawes, MD Florida Hospital

Responsible Party: Florida Hospital Identifier: NCT02039115     History of Changes
Other Study ID Numbers: 461672
First Posted: January 17, 2014    Key Record Dates
Results First Posted: September 8, 2017
Last Update Posted: September 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Esophageal Stenosis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents