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临床试验/NCT01356030
NCT01356030已完成不适用

Prospective Comparison of EUS-guided FNA and ERCP Tissue Sampling for the Diagnosis of Suspected Pancreato-biliary Neoplasms

California Pacific Medical Center Research Institute2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Direct comparison of tissue sampling techniques for patients with suspected pancreaticobiliary cancers.

研究概览

简要总结

The two most commonly used methods to biopsy suspected pancreaticobiliary masses are (1) endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) and (2) cytology brush biopsies obtained during endoscopic retrograde cholangiopancreatography (ERCP). At most centers, the specific method used depends on the availability of the technology and local expertise. Although it is believed that EUS-FNA is more accurate than ERCP brushings, there have been no head-to-head comparisons. The investigators' hypothesis is that EUS-FNA is superior to ERCP in obtaining tissue biopsies of pancreaticobiliary tumors, and the investigators aim to directly compare the two techniques.

详细描述

Patients with pancreaticobiliary tumors usually present with painless jaundice due to bile duct obstruction. The standard clinical evaluation may include EUS and/or ERCP. At centers where EUS is available (like CPMC), it is usually used first as it is generally considered a better tool for tumor detection, staging, and performing biopsies (FNA). ERCP is then performed, if needed, to place a stent and relieve jaundice. As EUS is a relatively newer technology that has not widely disseminated, other centers use ERCP as the 1st modality to evaluate suspected malignant pancreaticobiliary obstruction. The role of ERCP in this setting is to not only place a stent to relieve jaundice, but to additionally obtain cytology brushings for tissue diagnosis.

Several studies have reported high sensitivity of EUS-FNA for detecting pancreaticobiliary cancers that are causing bile duct obstruction and jaundice (80-90%). The sensitivity for ERCP brushings and biopsies to detect the same types of tumors is reportedly lower (30-80%), but there have been no direct comparisons of these techniques.

Few centers use both technologies (EUS and ERCP) for patient care, or often perform EUS and ERCP at separate sessions. At CPMC, the investigators routinely perform EUS and ERCP together for patients needing these procedures. Thus the investigators are in a unique position to directly compare EUS-FNA to ERCP brushings for tissue diagnosis of suspected pancreaticobiliary tumors.

The proposed study will be the 1st direct comparison of EUS-FNA to ERCP tissue sampling for patients with suspected pancreaticobiliary cancers. Study results will highlight the best approach to obtain a biopsy diagnosis of pancreatic and biliary tract cancers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age >18 years that are scheduled for EUS and possible ERCP for the evaluation of jaundice from suspected pancreaticobiliary tumors.

排除标准

  • Patients that do not provide consent for EUS and ERCP (for standard clinical reasons)
  • Patients that do not require ERCP based on EUS findings (e.g. no mass seen, mass is not causing jaundice
  • Patients in whom an additional 5 minutes of procedure time may increase the procedural/sedation risks:
  • pregnant patients
  • patients with severe medical co-morbidities (ASA class 4 or 5)
  • Patients with significant bleeding risk precluding endoscopic tissue sampling
  • INR > 1.4 or Prothrombin time > 5 sec more than control
  • Platelet count < 50,000

结局指标

主要结局

Direct comparison of tissue sampling techniques for patients with suspected pancreaticobiliary cancers.

时间窗: One year

Diagnostic yield from EUS-FNA samples will be compared to yield from ERCP tissue sampling methods (brushings and forceps biopsies).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Janak Shah, MD

Director of Pancreatic and Biliary Endoscopy

California Pacific Medical Center Research Institute

研究点 (2)

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