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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

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:

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

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

NCT ID

NCT02039115

First Posted

January 15, 2014

Last Updated

August 8, 2017

Sponsor

AdventHealth

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

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

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

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Reduction in Symptomatic Esophageal Stricture Formation

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