Acetic Acid Guided Biopsies in Barrett's Surveillance for Neoplasia Detection Versus Non-targeted Biopsies (Seattle Protocol): A Feasibility Study for a Randomised Tandem Endoscopy Trial. The ABBA Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Feasibility as assessed by the ratio of patients approached to recruited, percentage of patients who complete both endoscopies
研究概览
简要总结
Problem statement Barrett's oesophagus is a pre-cancerous condition affecting 375,000 people in the U.K. There is a 0.5-3% yearly risk of progressing to oesophageal cancer, from which only 5% of patients will survive for 5 years after diagnosis. Diagnosing the disease at the stage of dysplasia (pre-cancerous) and early cancer improves survival. This has led to the current surveillance strategy of gastroscopy with non-targeted mapping biopsies taken from the Barrett's oesophagus every two years. The large number of biopsies required is time consuming and expensive, yet dysplasia and cancerous tissue is still missed due to the non-targeted biopsy sampling strategy. Acetic acid has been used effectively in the early detection of cervical dysplasia and cancer, and has also been used with success in a high risk Barrett's population (patients with suspected dysplasia or previously treated dysplasia), but not been studied in the lower risk Barrett's surveillance population. A diagnostic study of non-targeted mapping biopsies (current practice) versus targeted biopsies (acetic acid) in a surveillance population is needed before widespread adoption of this technique is possible.
详细描述
This is a feasibility study to enable powering of a larger study. The investigators would assume a disease detection of 4.5% with acetic acid chromoendoscopy and 1.5% with protocol driven mapping biopsies. However, these assumptions are largely driven from a single centre cohort study and as such need clarification before they could be used for the purposes of powering a study. Based on the historical cohort studies and wide consultation within the British Society of Gastroenterology research committee and consultation with experts in the field, it is estimated that 200 patients would be reasonable for recruitment to enable the reproducibility and generalisability of this data to be established. The purpose of this study is not to produce statistically significant data in itself but to establish likely event rates and effect size to inform the power calculation for the definitive study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or above
- •Biopsy proven Barrett's metaplasia
- •At least 2cm of Barrett's metaplasia (C0 M2)
- •Willing and able to give informed consent
排除标准
- •Less than 2cm (C0 M2) of Barrett's metaplasia
- •Significant oesophagitis
- •Known or prior oesophageal cancer
- •Known or prior oesophageal dysplasia (indefinite for dysplasia CAN be included)
- •Previous endoscopic therapy
- •Known allergy to acetic acid
- •Previous inclusion in the study
研究组 & 干预措施
Non targeted quadrantic biopsies
Patients undergo current gold standard Barrett's surveillance with quadrantic Seattle protocol biopsies
干预措施: Non targeted quadrantic biopsies (Procedure)
Acetic Acid targeted biopsies
Patients undergo dye spray gastroscopy with Acetic Acid and targeted biopsies for areas of dysplasia.
干预措施: Acetic Acid (Drug)
结局指标
主要结局
Feasibility as assessed by the ratio of patients approached to recruited, percentage of patients who complete both endoscopies
时间窗: 18 months
To determine the feasibility of recruiting 200 Barrett's surveillance patients in 18 months. Ratio of patients approached to recruited, percentage of patients who complete both endoscopies.
次要结局
- Participant acceptability of trial design(18 months)
- Comparison of dysplasia rates as assessed by the number of biopsies in each endoscopy required to detect dysplasia(18 months)
- Feasibility of training in Acetic Acid technique(18 months)
- Clinician's acceptability of using Acetic Acid technique(18 months)
- Facilitators and barriers to recruitment(18 months)
- Number of adverse events(18 months)