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Reduction in Symptomatic Esophageal Stricture Formation

Primary Purpose

Esophageal Stenosis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
prednisone
placebo
Sponsored by
AdventHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Stenosis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

prednisone

placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Stricture Formation
Primary outcome measure is the rate of symptomatic esophageal stricture formation.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2014
Last Updated
August 8, 2017
Sponsor
AdventHealth
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1. Study Identification

Unique Protocol Identification Number
NCT02039115
Brief Title
Reduction in Symptomatic Esophageal Stricture Formation
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Closed for low enrollment and the inability to complete the study.
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stenosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prednisone
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets will be taken in the same manner as the prednisone arm.
Intervention Type
Drug
Intervention Name(s)
prednisone
Other Intervention Name(s)
steroid
Intervention Description
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
Intervention Name(s)
placebo
Other Intervention Name(s)
control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stricture Formation
Description
Primary outcome measure is the rate of symptomatic esophageal stricture formation.
Time Frame
98 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hawes Hawes, MD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reduction in Symptomatic Esophageal Stricture Formation

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