A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia (The SURVENT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 680
- 试验地点
- 54
- 主要终点
- Neoplastic Progression
研究概览
简要总结
The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy.
To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells.
Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments.
While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other.
Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia.
This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data.
详细描述
Methodology:
Patients with Barrett's esophagus and low grade dysplasia will be recruited in the multicenter trial. Patients will be randomized into endoscopic eradication therapy or endoscopic surveillance.
Subjects in the randomized control trial and observational cohort study, undergoing surveillance endoscopy will undergo surveillance biopsies in a 4-quadrant fashion every 1 cm throughout the extent of the Barrett's Esophagus using the Seattle biopsy protocol, along with targeted biopsies from any visible lesions. For incident low grade dysplasia (newly diagnosed low grade dysplasia - within 12 months of enrollment), surveillance endoscopies will be performed every 6 months for the first year and then annually until the end of the study period. For prevalent low grade dysplasia (diagnosed >1 year prior to enrollment), surveillance endoscopies will be performed annually until the end of the study period. The number of evaluations will depend on a subject's enrollment time with a maximum follow up period of 4years.
Subjects undergoing endoscopic eradication therapy will undergo radiofrequency ablation every 2-3 months until complete eradication of intestinal metaplasia (CE-IM) is achieved or 5 treatments have been delivered, whichever is first. After achieving CE-IM, surveillance endoscopy will performed every 6 months for the first year and annually thereafter until the end of the study period. Surveillance biopsies will be obtained using a standardized protocol.
Subjects will be contacted 48-72 hours and 30 days post procedure. All subjects will also receive follow-up phone calls on a semi-annual basis by a blinded central study coordinator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND:
- •Meets all the following criteria will be eligible for enrollment:
- •Male or female, age ≥18 years;
- •Subject has endoscopic evidence of Barrett's esophagus characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas demonstrating columnar metaplasia with goblet cells. This inclusion criterion will exclude patients with intestinal metaplasia with dysplasia of the gastric cardia;
- •Biopsies within the previous 12 months demonstrating Barrett's esophagus and indeterminate for dysplasia or low grade dysplasia;
- •Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months;
- •Demonstrated ability to tolerate proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) therapy based on patient self-report; and,
- •Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures.
排除标准
- •Prior endoscopic eradication therapy for Barrett's esophagus;
- •History of high grade dysplasia or esophageal adenocarcinoma;
- •History of esophageal resection/esophagectomy
- •Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis;
- •Esophageal strictures precluding passage of the endoscope or treatment catheters - patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy;
- •Esophageal varices or known portal hypertension; and
- •Life expectancy of <2 years as judged by the site investigator. * Patients are eligible for enrollment and randomization if they meet the above eligibility criteria. It should be noted that the presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion. Those with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology. If HGD or EAC pathology is determined, then the subject will exit from the study after a 30-day safety follow up
研究组 & 干预措施
Endoscopic Surveillance
Subjects in the randomized control trial and observational cohort study, undergoing surveillance endoscopy will undergo surveillance biopsies in a 4-quadrant fashion every 1 cm throughout the extent of the Barrett's esophagus using the Seattle biopsy protocol, along with targeted biopsies from any visible lesions. For incident low grade dysplasia (newly diagnosed low grade dysplasia - within 12 months of enrollment), surveillance endoscopies will be performed every 6 months for the first year and then annually until the end of the study period. For prevalent low grade dysplasia (diagnosed >1 year prior to enrollment), surveillance endoscopies will be performed annually until the end of the study period. The number of evaluations will depend on a subject's enrollment time.
Endoscopic Eradication Therapy
Subjects undergoing endoscopic eradication therapy will undergo radiofrequency ablation every 2-3 months until complete eradication of intestinal metaplasia (CE-IM) is achieved or 5 treatments have been delivered, whichever is first. After achieving CE-IM, surveillance endoscopy will performed every 6 months for the first year and annually thereafter until the end of the study period. Surveillance biopsies will be obtained using a standardized protocol.
干预措施: Endoscopic Eradication Therapy (Procedure)
结局指标
主要结局
Neoplastic Progression
时间窗: Baseline, through study completion
The occurrence of high grade dysplasia/mucosal post-endoscopy esophageal adenocarcinoma/invasive post-endoscopy esophageal adenocarcinoma at any time during the study period following enrollment.
次要结局
- Work Productivity and Activity(Baseline, through study completion)
- Biomarker Utility(Baseline, through study completion)
- Esophageal Adenocarcinoma (EAC) progression rate(Baseline, through study completion)
- Patient-Reported Depression, Anxiety, and Gastrointestinal Symptoms(Baseline, through study completion)
- Patient-Reported Gastroesophageal Reflux(Baseline, through study completion)