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EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis (EYE/SPY)

2026年5月26日 更新者：David KARSENTI

Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech).
设备：EYEMAX® cholangioscopy system
Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the EYEMAX® working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.
有源比较器：Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific).
设备：SPYGLASS™ DS system
Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS cholangioscopy system (Boston Scientific) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the SPYGLASS™ DS working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
大体时间：Through study completion, an average of 1 year
The positive diagnostic yield will be assessed for the first four biopsies obtained under cholangioscopy in patients with adenocarcinomatous biliary strictures. This rate will be defined as the ratio between the number of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies and the total number of confirmed adenocarcinomatous biliary strictures.
Through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
Positive diagnostic yield of all eight cholangioscopy-guided biopsies
大体时间：Through study completion, an average of 1 year
This rate will be defined as the proportion of positive pathological diagnoses obtained from all eight cholangioscopy-guided biopsies among all confirmed adenocarcinomatous biliary strictures.
Through study completion, an average of 1 year
Histological cellularity classification of cholangioscopy-guided biopsy specimens
大体时间：Through study completion, an average of 1 year
Biopsy specimen cellularity will be assessed by expert gastrointestinal pathologists and classified into four predefined categories: acellular, low abundance, satisfactory abundance, or rich abundance.
Through study completion, an average of 1 year
False negative rate of cholangioscopy-guided biopsies
大体时间：Through study completion, an average of 1 year
The false negative rate will be defined as the proportion of patients with negative biopsy results despite a final diagnosis of adenocarcinomatous biliary stricture confirmed during follow-up.
Through study completion, an average of 1 year
Negative predictive value of cholangioscopy-guided biopsies
大体时间：Through study completion, an average of 1 year
Negative predictive value will be calculated as the proportion of patients with negative biopsy results who do not have adenocarcinomatous biliary strictures at final diagnosis.
Through study completion, an average of 1 year
Percentage of technical failures during cholangioscopy-guided biopsy procedures
大体时间：Periprocedural
Technical failure will be defined as the inability to access the biliary stricture with the cholangioscope or the inability to obtain biopsy material using the dedicated biopsy forceps.
Periprocedural
Diagnostic yield of additional biliary sampling techniques
大体时间：Through study completion, an average of 1 year
The diagnostic yield of additional biliary sampling techniques, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling, will be evaluated as the proportion of positive pathological diagnoses obtained using each technique.
Through study completion, an average of 1 year
Number of participants with procedure-related adverse events
大体时间：Up to Day 30
Procedure-related adverse events include abdominal pain, acute pancreatitis, cholangitis, cholecystitis, hepatic abscess, perforation, bleeding, and death.
Up to Day 30
Mean duration of cholangioscopy-guided biopsy procedures
大体时间：Periprocedural
The duration required to complete the eight cholangioscopy-guided biopsies will be measured and compared between the two cholangioscopy systems.
Periprocedural

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

David KARSENTI

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2029年9月1日

研究完成 (估计的)

2030年9月1日

研究注册日期

首次提交

2026年5月19日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SFED-160

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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