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.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- AdventHealth
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Stricture Formation
研究概览
简要总结
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.
详细描述
The main objective of the proposed randomized trial is to compare the rate of symptomatic oesophageal strictures in patients receiving placebo versus oral prednisone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Barretts mucosa with high grade dysplasia or early esophageal adenocarcinoma (T1a, intramucosal adenocarcinoma).
- •Barretts segment ≥ 30% circumference, ≤C3 and ≤M
- •The general health condition of the patient permits anesthesia for endoscopy.
- •Patient is 18 years of age or older.
- •Informed consent is obtained
排除标准
- •Previous (referral) biopsies show low grade dysplasia only, or invasive adenocarcinoma.
- •Barretts segment <30% circumference, >C3 or >M
- •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
研究组 & 干预措施
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.
干预措施: prednisone (Drug)
placebo
Placebo tablets will be taken in the same manner as the prednisone arm.
干预措施: placebo (Drug)
结局指标
主要结局
Stricture Formation
时间窗: 98 weeks
Primary outcome measure is the rate of symptomatic esophageal stricture formation.
次要结局
未报告次要终点