EMUNE-07 Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer can reduce the number of passes needed to obtain a preliminary cytological diagnosis of neoplasia.
研究概览
简要总结
The aim of this study is to evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer allows an earlier preliminary cytological diagnosis of neoplasia.
详细描述
This is a prospective randomized controlled trial which will recruit patients referred for suspicion of pancreatic mass and indication of EUS-FNA as part of standard of care in the Interventional Endoscopy Unit at the University Of Chicago Medical Center. Basic demographic data will be recorded for each patient. If a pancreatic mass is confirmed in EUS evaluation the patient will be randomized in a 1:1 ratio to either Control group (Single needle) or Investigational group (Multiple Needle). There will be an expert cytopathologist in the exploration room (blinded to the group assignment). Samples obtained through FNA will be prepared onsite either for cytological evaluation by the cytopathologist: each fine needle sample will be expressed by using a 10mL air-filled syringe onto a separate glass slide, and a direct smear will be made by an on-site cytopathologist. Each slide will be air-dried and/or alcohol fixed (95% ethanol), and direct smears will be prepared for immediate interpretation by staining with Diff-quick staining system.
Patients assigned to simple needle group (SN) will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
Patients assigned to multiple needle group (MN) will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
A cytopathologist (#1) will be present during each EUS-FNA procedure to prepare the slides and determine whether each specimen was adequately cellular. After the procedure, all the cytological samples will be sent to the Pathology department in order to complete the study. A cytopathologist (#2) not present during the procedure will study all the sampling specimens obtained during the EUS-FNA procedure and produce the final and definitive cytopathological diagnosis.
Criteria for pancreatic cancer and benign pancreatic lesions will be defined. Follow-up of all patients to assess early and late complications will be carried out for 30 days after the procedure.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspicion of pancreatic mass due to previous exam/s (CT, MR, ERCP, US, ...) that requires EUS-FNA in order to complete diagnosis
- •Age ≥ 18 y/o
- •Formal informed consent
- •No previous chemotherapy or radiotherapy
- •No previous pancreatic surgery
排除标准
- •Any patient unable to understand the procedure, nature of the current study, or sign a consent form.
结局指标
主要结局
Evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer can reduce the number of passes needed to obtain a preliminary cytological diagnosis of neoplasia.
时间窗: October 2007- September 2008
次要结局
- Rate of complications related with EUS-FNA(October 2007- September 2008)
- Influence of different factors in obtaining a positive cytological result(October 2007- September 2008)