BRIDE (Barrett&Apos;s Randomised Intervention for Dysplasia by Endoscopy) - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 6
- 主要终点
- Recruitment rate and retention
研究概览
简要总结
LAY SUMMARY
A type of gullet cancer (oesophageal adenocarcinoma) has become the 5th commonest UK cause of cancer death. Unfortunately, by the time patients have symptoms, the cancer is often incurable. People with Barrett's oesophagus (change of gullet lining occurring in some with acid reflux) at risk of this cancer can have regular check-ups, involving examination through an endoscope (an instrument inserted by mouth, under mild sedation if required). A small proportion of people with Barrett's develop further changes (which might become cancer) in the gullet lining; if they do, it is important to remove the affected tissue before cancer develops, or when it is at an early stage.
There are several ways of removing this tissue but the investigators do not know which is best. The standard treatment is surgery, but there is a small risk of dying from the operation, and patients often suffer complications affecting them for a year or more afterwards. Two endoscopic treatments do not involve surgery. Both involve removing visible abnormalities by a technique called endoscopic resection, followed by cauterising the remaining Barrett's gullet lining by 1 of 2 techniques. One is recommended by the National Institute for Health and Clinical Excellence, but it is expensive and less widely available than the second. No-one has compared these treatments with each other, nor with surgery, in randomised trials (the most reliable way of deciding which is best). Patient groups say they would prefer to avoid surgery if the alternative works, and have encouraged us to do trials.
This feasibility study is a vital step towards two trials: (a) a trial to compare the two non-surgical techniques and (b) a trial comparing surgery with endoscopic treatment. It will help us find out whether it will be possible to enroll and retain enough patients by using several centres, and to identify/resolve any other potential barriers to recruitment and retention, including exploring viewpoints of patients and surgeons.
详细描述
The study will comprise 2 parts:
Firstly, randomising up to 100 suitable patients over a 1 year period, identified at the upper gastrointestinal cancer specialist multidisciplinary team meeting in 6 expert English centres. Patients will have either high grade dysplasia (HGD) or early cancer in Barrett's oesophagus (BE) and will be randomised to two curative endoscopic non-surgical therapies (endoscopic resection [ER] and argon plasma photocoagulation [APC] versus ER and radiofrequency ablation [RFA]). All techniques are used in current clinical practice, but have never been directly compared.
Secondly, 2 qualitative studies in which we will examine clinicians' and surgeon's attitudes towards a trial of oesophageal surgery compared to endoscopic treatment (ER and ablation) by questionnaire. Qualitative interviews with a purposive sample of patients will explore their views of randomisation, recruitment and participation to help identify and pre-empt problems in subsequent planned trials of endoscopic treatments compared to each other and to surgical removal of all or part of the gullet.
Participants will be randomised to the ER plus RFA or ER plus APC group at enrollment. The randomisation schedule will be managed by the University of Leicester Clinical Trials Unit, using a computer generated random assignment.
Randomisation will be stratified for length of Barrett's epithelium (< 5; 5-10; > 10 cm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology: high grade dysplasia (HGD) or early cancer with a maximum depth of invasion on endoscopic resection (ER) of T1m3
- •Endoscopic ultrasound if any endoscopically visible abnormality: negative for T2 invasion or greater, and for suspicious lymph nodes.
- •CT scan (thorax & top 1/3 of abdomen): negative for evidence of locally advanced or metastatic disease (done at the discretion of the multidisciplinary team, for invasive cancer only - T1m disease); PET-CT will not usually be required but may be carried out if indicated at the discretion of the multidisciplinary team.
- •Suitability for trial agreed at local upper gastrointestinal cancer multidisciplinary team (MDT).
- •Able to give informed consent
- •Able (if applicable) to discontinue Clopidogrel for 7 days before & after endotherapy i.e. 14 days in total.
- •Able (if applicable) to discontinue Warfarin with or without a bridging plan using low molecular weight heparin. The Warfarin can be restarted 1-7 days after endotherapy according to the local endoscopist's usual clinical practice.
排除标准
- •Histology: depth of invasion beyond muscularis mucosae histologically (> T1m), poorly differentiated T1m cancers or lymphatic invasion or vascular invasion.
- •Short tongues (<2 cm) of Barrett's epithelium that could be completely removed by Endoscopic Resection
- •No localised endoscopically identifiable abnormality by high definition endoscopy (with or without magnification or chromo-endoscopic techniques)
- •Prior oesophageal endoscopic therapy: e.g. Photodynamic Therapy, Endoscopic resection, prior ablation by other techniques such as argon ablation.
- •Existing symptomatic stricture or one caused by the study diagnostic ER unless this can be dilated and the patient is then judged to be suitable for endoscopic treatment by the expert endoscopist.
- •History of: radiation to mediastinum, oesophageal surgery (except fundoplication without complication), oesophageal varices or coagulopathy.
结局指标
主要结局
Recruitment rate and retention
时间窗: 12 months
BRIDE is a feasibility study randomising up to 100 patients with high grade dysplasia or early cancer in Barrett's oesophagus to two curative endoscopic non-surgical therapies (endoscopic resection and argon plasma photocoagulation versus endoscopic resection and radiofrequency ablation). Primary outcome measures at 12 months after baseline are: - Recruitment rate and retention The primary aim is to gain information that will enable realistic estimation of recruitment/retention rates in order to inform a fully powered trial (BRIDE 2) comparing the 2 endoscopic treatment techniques.
次要结局
- Quality of life(12 months)
- Endotherapy complications(8 months (treatment period))
- Qualitative interviews with a subset of patients(12 months)
- Clinician questionnaires on attitudes to surgery and endotherapy in early neoplastic Barrett's oesophagus.(12 months)
- Health economic assessment(12 months)