Reduction in Symptomatic Esophageal Stricture Formation

NCT02039115 | Terminated Phase 4 Results DMC

• 1 other identifier: 461672
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Stenosis

Outcome Measures

Primary Outcomes (1)

• Stricture Formation

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

  98 weeks

Study Arms (2)

prednisone

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

prednisone DRUG

6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision.

Also known as: steroid

prednisone

placebo DRUG

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.

Also known as: control

placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Esophageal Stenosis

Interventions

Prednisone; Steroids

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Robin (Barron-Nelson) Kangas
• Organization: Center for Interventional Endoscopy

Robin.Barron@flhosp.org

407.303.5503

Study Officials

• Robert Hawes Hawes, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: September 8, 2017
• Results First Posted: September 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)