Registry of Endoscopic Ultrasound Guided Assessment of the Liver (REGAL Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 主要终点
- Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 1]
研究概览
简要总结
Patient Registry aiming to provide regional evidence documenting the clinical merit of EUS (Endoscopic_ Ultrasound) guided liver biopsy, per local standard of practice, in patients with suspected liver disease indicated for an endoscopic intervention and a liver biopsy.
详细描述
The finding of this patient Registry may lead to recommendations towards optimizing liver biopsy procedures. If the study demonstrates the optimization of the number of interventions needed to reach diagnostic and therapeutic goals in the setting of suspected liver disease thanks to the utilization of Acquire compared to other liver biopsy procedures, this data can be used as part of economic messaging of the BSC Acquire Fine Needle Biopsy.
This Registry will document all relevant diagnostic and therapeutic radiologic - trans jugular or percutaneous - and endoscopic/endosonographic interventions which enrolled patients undergo when they are suspected to have liver disease and are indicated for an endoscopic procedure and liver biopsy. The study will help illustrate that an EUS guided approach for liver biopsy in patients with suspected liver disease that is indicated for:
Upper endoscopy and Liver biopsy will benefit both the patients and the hospitals from completing both procedures in one setting.
Where possible, the proposed Registry will also allow for the dynamic assessment of the severity of liver disease and for monitoring of changes to therapy for liver fibrosis and/ or portal hypertension. It is anticipated that the ability to monitor changes in liver status over time will become increasingly important as new therapies emerge in the field.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (per local age threshold)
- •Suspected liver disease based on abnormal liver function tests, standard ultrasound, transient elastography (Fibro Scan) or CT or MRI of the liver
- •Planned upper endoscopy to evaluate for varices
- •Planned liver biopsy based on suspected hepatitis or cirrhosis
排除标准
- •Severe Coagulation/bleeding disorder as defined by INR > 2 IU which cannot be corrected with FFP or Platelets < 50,000 per microliter which cannot be corrected with platelet transfusion.
- •Severe organ failure considered unsafe to undergo sedation (ASA class 4 or 5)
- •Inability to provide informed consent
结局指标
主要结局
Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 1]
时间窗: 30 Days in Phase 1
Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 30 days after the first upper Endoscopy procedure on study \[ Phase 1\]
Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 2]
时间窗: 12 months in phase 2
Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 12 months after the first upper Endoscopy procedure on study \[ Phase 2\]
次要结局
- Number of serious adverse events(30 days (Phase 1), 12 months (Phase 2))
- Number of Participants with Laboratory Abnormalities in Liver function Tests(from baseline to 6 months and from baseline to 12 months [Phase 2])
- Number of diagnostic liver biopsies(13 months (phase 1 and 2))
- Number of Participants with Noninvasive Liver Imaging abnormalities(from baseline to 6 months and from baseline to 12 months [Phase 2])