Esophageal Stenosis
Conditions
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.
Interventions
DRUGprednisone
6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision.
DRUGplacebo
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.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stricture Formation | 98 weeks | Primary outcome measure is the rate of symptomatic esophageal stricture formation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prednisone 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.
prednisone: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision. | 1 |
| Placebo Placebo tablets will be taken in the same manner as the prednisone arm.
placebo: 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. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Prednisone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Stricture Formation
Primary outcome measure is the rate of symptomatic esophageal stricture formation.
Time frame: 98 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisone | Stricture Formation | 1 Participants |
| Placebo | Stricture Formation | 0 Participants |