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Reduction in Symptomatic Esophageal Stricture Formation

NCT02039115 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-09-08

Study results available
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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.

Conditions

  • Esophageal Stenosis

Interventions

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.

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.

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Robert Hawes Hawes, MD · AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039115 on ClinicalTrials.gov