Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity remains suboptimal, partly because of the small diameter of the dedicated biopsy forceps.
The EYEMAX® cholangioscopy system has a larger working channel, potentially allowing the use of larger biopsy forceps and improved tissue acquisition. This multicenter randomized study aims to compare the diagnostic performance of EYEMAX® versus SPYGLASS™ DS for the diagnosis of malignant biliary strictures.
The primary objective is to compare the positive diagnostic yield of the first four cholangioscopy-guided biopsies obtained with each system in patients with adenocarcinomatous biliary strictures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Open Label with blinded pathology review
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adult patients aged 18 to 84 years
- •2. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture
- •3. Absence of a mass easily accessible to EUS-guided fine needle aspiration
- •4. ASA physical status 1-3
- •5. No participation in another clinical trial
- •6. Written informed consent obtained
- •7. Patient affiliated with a social security system or equivalent
排除标准
- •1. Lithiasic biliary obstruction
- •2. Patients younger than 18 years
- •3. ASA 4 or ASA 5 patients
- •4. Pregnant or breastfeeding women
- •5. Coagulation disorders preventing biopsy procedures
- •6. Surgical anatomy preventing papillary access
- •7. Patients unable to provide informed consent
- •8. Upper gastrointestinal obstruction
- •9. Intolerance to endoscopy
- •10. Severe cardiopulmonary disease
- •11. Acute pancreatitis or severe cholangitis
- •12. Severe contrast agent allergy
- •13. Patients under legal protection measures
研究者
David KARSENTI
Principal Investigator, Medical doctor
Société Française d'Endoscopie Digestive