Esophageal StenosisPhase 4NCT02039115
Reduction in Symptomatic Esophageal Stricture Formation
A Phase 4 study testing prednisone in people with Esophageal Stenosis, run by AdventHealth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Esophageal Stenosis
- What is being tested?
- prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Esophageal Stenosis
- Being tested
- prednisone, placebo
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
Also called steroid
6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision.
placeboDrug
Also called control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: prednisone |
| placebo | Placebo comparator | Placebo tablets will be taken in the same manner as the prednisone arm. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stricture Formation
Primary outcome measure is the rate of symptomatic esophageal stricture formation.
Measured: 98 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Closed for low enrollment and the inability to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Hawes Hawes, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039115
- Sponsor's protocol ID
- 461672
- Status last verified
- Aug 2017
- First submitted
- 15 Jan 2014
- Last updated
- 8 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02039115
- Acronym / sponsor ID
- 461672
- Conditions
- Esophageal Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed for low enrollment and the inability to complete the study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 8 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisone | Experimental | Drug: prednisoneDaily 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 | Placebo comparator | Drug: placeboPlacebo tablets will be taken in the same manner as the prednisone arm. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisoneAlso: steroid6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision. | Drug | prednisone |
| placeboAlso: control6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision. | Drug | placebo |
Primary outcome
Stricture Formation
Time frame: 98 weeks
Primary outcome measure is the rate of symptomatic esophageal stricture formation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hawes Hawes, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prednisone in people with Esophageal Stenosis, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stricture Formation (time frame: 98 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.