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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02004782
Registration number
NCT02004782
Ethics application status
Date submitted
25/11/2013
Date registered
9/12/2013
Date last updated
3/07/2023
Titles & IDs
Public title
Barretts oEsophageal Resection With Steroid Therapy Trial
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Scientific title
Reduction in Symptomatic Oesophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy: A Randomized, Doubleblind, Placebo-controlled, Multicentre Trial.
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Secondary ID [1]
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HREC2013/7/4.5(3702)
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Universal Trial Number (UTN)
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Trial acronym
BERST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Barrett Esophagus
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Esophageal Stenosis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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Oesophageal (gullet)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Prednisolone
Treatment: Drugs - Placebo Oral Tablet
Active Comparator: Prenisolone - Daily prednisolone is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Prednisolone 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 CBE.
Placebo Comparator: Placebo - Daily placebo is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Placebo 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 CBE.
Treatment: Drugs: Prednisolone
Daily prednisolone is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Prednisolone 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 CBE.
Treatment: Drugs: Placebo Oral Tablet
Daily placebo is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Placebo 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 CBE
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of symptomatic stricture formation
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Assessment method [1]
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Rate of symptomatic oesophageal stricture formation.A symptomatic stricture is defined as a stricture leading to the inability to tolerate a soft diet for = 2 days, or the presence of complete dysphagia for any length of time.
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Timepoint [1]
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>2 days
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Secondary outcome [1]
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Dilations
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Assessment method [1]
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The need for, and number of endoscopic dilations.
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Timepoint [1]
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Two weeks or more
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Secondary outcome [2]
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Dysphagia score
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Assessment method [2]
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Dysphagia score (DS) at 3, 6 and 12 month surveillance endoscopies. DS: 0 = Normal diet; 1 = Some solid foods; 2 = Semi-solid foods; 3 = Liquids only; 4 = Total dysphagia
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Timepoint [2]
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3, 6 and 12 months
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Secondary outcome [3]
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Stricture formation
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Assessment method [3]
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Endoscopic evidence of stricture formation at 3, 6 and 12 month surveillance endoscopies. No stricture, mild stricture, moderate stricture ('hugs' the gastroscope but the gastroscope can pass), severe stricture (cannot be passed with the gastroscope)
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Timepoint [3]
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3, 6, 12 months
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Secondary outcome [4]
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Recurrence
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Assessment method [4]
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Recurrence of Barretts mucosa, defined as the presence of Barretts mucosa endoscopically, or mucosal columnar epithelium with or without intestinal metaplasia on surveillance biopsies. Measured at 3-month surveillance (20 weeks post 1st CBE), 6 month surveillance (46 weeks post 1st CBE), and 12 month surveillance (98 weeks post 1st CBE) endoscopies.
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Timepoint [4]
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3, 6 and 12 months
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Eligibility
Key inclusion criteria
1. Histologically confirmed Barretts mucosa with High Grade Dysplasia or early
adenocarcinoma (T1a, intramucosal adenocarcinoma).
2. Barretts segment = 30% circumference, =C3 and =M5.
3. The general health condition of the patient permits anaesthesia for endoscopy.
4. Patient is 18 years of age or older.
5. Informed consent is obtained
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Previous (referral) biopsies show low grade dysplasia only, or invasive
adenocarcinoma.
2. Barretts segment <30% circumference, >C3 or >M5.
4. 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 CBE (60% circumferential resection) and
randomization after a 4-6 weeks interval.
4. Presence of a tight peptic oesophageal stricture that impedes safe and effective EMR
using the Duette cap.
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:
Microcrystalline cellulose (MCC).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/03/2022
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2022
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
Professor Michael Bourke
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Barretts mucosa is a premalignant condition of the oesophagus, which can progress to cancer.
Oesophageal cancer is aggressive, with a 5 year survival of only ~15%. High risk Barretts
mucosa, containing high grade dysplasia or early cancer, can be removed by endoscopic mucosal
resection (EMR) during gastroscopy. If patients can be effectively treated by EMR while they
have premalignant or early malignant disease, it is a curative procedure.
Currently, the major limitation of Complete Barretts Excision (CBE) by EMR, is scar tissue
development in the oesophagus, leading to stricture formation and difficulty swallowing
(dysphagia). If a safe and effective method could be found to reduce this risk, the treatment
options for early oesophageal cancer would be greatly improved. CBE is performed as a two
stage procedure, with 2 gastroscopies 8 weeks apart. In this randomised, doubleblind study,
eligible and enrolled patients are randomised after the 1st stage CBE to receive either
prednisolone tablets or placebo. Inclusion criteria are patients with short segment (<3cm
circumferential disease) Barretts oesophagus with high grade dysplasia or early cancer. The
treatment period is for 6 weeks after both CBE sessions. Prednisolone is given in a reducing
dose over the 6 weeks, starting at 40mg daily.
The primary outcome is symptomatic dysphagia development. Endoscopic dilation will be
performed as required for dysphagia secondary to symptomatic oesophageal stricture formation
persisting for =2 days, or complete dysphagia for any time period. Endoscopic surveillance
with biopsies will occur at a 3 month, 6 month then 12 month interval following CBE, to
assess for complete removal of Barretts mucosa.
Following two stage CBE, stricture rates without preemptive therapy in noncircumferential,
circumferential <2cm, and circumferential <3cm disease, are estimated to be 30%, 50% and 70%
respectively. The investigators predict a 50% reduction in stricture rate with oral steroid
therapy. With a primary analyses of oral steroid versus placebo tested at a 5% level of
significance in a two tailed test, 58 patients are needed per group. Allowing for a 5% drop
out rate, a total of 126 patients are required. The study will be performed at five
Australian Tertiary Hospitals, and the recruitment period is estimated to be 2 years.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02004782
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Michael Bourke
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Address
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Western Sydney Local Health District
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02004782
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