- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02039115
Reduction in Symptomatic Esophageal Stricture Formation
August 8, 2017 updated by: AdventHealth
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.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
3
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Orlando, Florida, United States, 32803
- Florida Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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.
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6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision.
Other Names:
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PLACEBO_COMPARATOR: placebo
Placebo tablets will be taken in the same manner as the prednisone arm.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stricture Formation
Time Frame: 98 weeks
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Primary outcome measure is the rate of symptomatic esophageal stricture formation.
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98 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Hawes Hawes, MD, AdventHealth
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (ACTUAL)
February 1, 2015
Study Completion (ACTUAL)
February 1, 2015
Study Registration Dates
First Submitted
January 15, 2014
First Submitted That Met QC Criteria
January 15, 2014
First Posted (ESTIMATE)
January 17, 2014
Study Record Updates
Last Update Posted (ACTUAL)
September 8, 2017
Last Update Submitted That Met QC Criteria
August 8, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 461672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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