A Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,298
- 试验地点
- 27
- 主要终点
- Diagnostic yield of intestinal metaplasia (Screening population only)
研究概览
简要总结
The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).
Barrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer.
Endoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a 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.
Patients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).
Patients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE.
While both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other.
Participants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized.
Up to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.
详细描述
Methodology:
Patients with non-dysplastic Barrett's esophagus (BE) undergoing surveillance and patients meeting criteria for screening for BE with columnar-lined esophagus detected at endoscopy will be recruited in this multicenter randomized controlled trial.
All patients will undergo upper endoscopy using high-definition white light endoscopy and electronic chromoendoscopy (NBI/FICE). The findings (detection of visible lesions/abnormal mucosal or vascular pattern) with electronic chromoendoscopy will be recorded.
Patients will be randomized to receive sampling using either the Seattle biopsy protocol or WATS3D. The Seattle protocol will entail obtaining random biopsies every 2 cm in a 4-quadrant fashion. Biopsies will be taken from any visible lesion (no matter how subtle) and will be submitted in separate jars and excluded from the comparative analysis of the study. The WATS3D procedure will be conducted using a standardized protocol. Patients will then receive sampling using the technique to which they were not assigned to by randomization. This allows for all patients to receive standard of care (sampling using the Seattle biopsy protocol), and to determine concordance between the two sampling techniques acknowledging that one sampling technique could potentially affect the results of other sampling technique.
In patients with discordant results (WATS3D positive and random biopsy negative), repeat upper endoscopy with sampling using the Seattle biopsy protocol will be performed in an attempt to confirm the findings noted at WATS3D. This will be performed in the surveillance and screening population. Biopsy specimens will be submitted for histopathologic examination for routine clinical care. For the purpose of this study, all biopsy specimens will be sent to the Cleveland Clinic for interpretation by a central GI pathologist who will be blinded to patient details and to reading by the WATS3D pathologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
- •Surveillance Population
- •Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia/indefinite for dysplasia with NDBE at last endoscopy can be included)
- •Barrett's esophagus (BE) length of at least M1
- •English and Spanish speaking
- •Able to comprehend and complete the consent form
- •Age18-89 years
- •Life-expectancy of at least 2 years
- •Screening Population
- •Undergoing endoscopy for screening of BE
- •BE length of at least M1
- •English and Spanish speaking
- •Able to comprehend and complete the consent form
- •Age 18-89 years
- •Expected life-expectancy of at least 2 years
- •All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study.
排除标准
- •Surveillance Population
- •BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC)
- •Active erosive esophagitis with LA Grade B or higher
- •Esophageal varices
- •Prior history of EET
- •Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication
- •Pregnancy
- •Screening Population
- •BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC
- •Active erosive esophagitis with LA Grade B or higher
- •Esophageal varices
- •Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication
- •Pregnancy
研究组 & 干预措施
Seattle protocol, then WATS3D brushings.
Participants in the screening or surveillance population that receive the Seattle protocol, then WATS3D brushings, during the same procedure.
干预措施: WATS3D brushings (Diagnostic Test)
Seattle protocol, then WATS3D brushings.
Participants in the screening or surveillance population that receive the Seattle protocol, then WATS3D brushings, during the same procedure.
干预措施: Seattle protocol (Diagnostic Test)
WATS3D brushings, then Seattle Protocol.
Participants in the screening or surveillance population that receive the WATS3D brushings, then the Seattle protocol, during the same procedure.
干预措施: Seattle protocol (Diagnostic Test)
WATS3D brushings, then Seattle Protocol.
Participants in the screening or surveillance population that receive the WATS3D brushings, then the Seattle protocol, during the same procedure.
干预措施: WATS3D brushings (Diagnostic Test)
结局指标
主要结局
Diagnostic yield of intestinal metaplasia (Screening population only)
时间窗: up to 1 year
Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include intestinal metaplasia. All positive results for intestinal metaplasia/dysplasia or esophageal adenocarcinoma (EAC) with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.
Diagnostic yield of dysplasia (Surveillance population only)
时间窗: up to 1 year
Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). All positive results for dysplasia or EAC with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.
次要结局
- Detection of intestinal metaplasia (Surveillance population only)(baseline)
- Time of procedure as measured by total sampling time (Surveillance population only)(baseline)
- Diagnostic yield between the Seattle protocol and WATS3D Vs. the Seattle protocol alone (Surveillance population only)(up to 1 year)
- Interobserver agreement among pathologists for WATS3D specimens (Surveillance population only)(up to 6 months)
- Predictors of dysplasia in patients with non-dysplastic BE (Surveillance population only)(up to 5 years)
- Quality adjusted life years (Surveillance population only)(up to 5 years)
- Number of patients referred for endoscopic eradication therapy (EET) between Seattle protocol and WATS3D (Surveillance population only)(up to 1 year)
- Counts of participants with a biomarker or panel of biomarkers associated with increased risk of progression(up to 5 years)
- Diagnostic yield of dysplasia (Screening population only)(up to 1 year)