Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Cellularity Captured in Fine Needle Biopsies for the Heparin Group
研究概览
简要总结
This is a randomized study that will enroll patients scheduled for an endoscopic ultrasound biopsy of a pancreas lesion to be in the heparin or saline group during the procedure.
The purpose of this study is to examine the effect of blood contamination, heparin priming of the fine needle biopsies, and pass number on tumor tissue quality in fine needle biopsies.
The hypothesis for this study is that fine needle biopsy tissue quality of pancreatic masses decreases with increasing pass number due to blood contamination; this blood contamination can be ameliorated with priming of the needle with an anticoagulant such as heparin.
详细描述
A total of 3 fine-needle biopsy passes will be performed on every procedure. The tissue specimens from each of the 3 passes will be collected in 3 separate jars of 10% formalin for tissue analysis. The use of heparin flushing vs. not heparin flushing will be based on their randomized group assignments.
In the heparin arm, between passes, after tissue is extracted from the needle, the needle will be flushed with 1 mL of heparin (100 USP/mL) and flushed with air before the next pass will be made. This means the needle will have no heparin during the first pass. In the standard of care arm, between passes, after tissue is extracted from the needle, the needle will be flushed with saline and/or air as per current standards of care.
This study was amended at the Institutional Review Board (IRB) after having enrolled only two participants. Following the amendment, the responsible party changed and with that change some adjustments were made to the interventions, analysis and some outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The pathologist will be blinded to the allocation
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
- •Patient identified as having a possible solid pancreatic lesion on computed tomography or magnetic resonance
- •Patient scheduled for Endoscopic ultrasound (EUS) for sampling of pancreatic mass
排除标准
- •known history of coagulopathy
- •history of heparin allergy
- •patients with evidence of vascular tumors on imaging
- •Patients with history of chronic pancreatitis
- •Pregnant patients
- •Medically unstable patients
研究组 & 干预措施
Heparin priming biopsies
干预措施: Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe) (Combination Product)
Standard of care (saline)
干预措施: Saline (Drug)
结局指标
主要结局
Cellularity Captured in Fine Needle Biopsies for the Heparin Group
时间窗: Day 1 (biopsy tissue obtained)
Hematoxylin and eosin (H\&E) slides from the passes 1, 2, and 3 will be compared. The number of cells present on each H\&E slide will be quantified by using image processing software. This value will be total number of cells divided by the total area of the biopsy.
Blood Contamination in Fine Needle Biopsies for the Heparin Group
时间窗: Day 1 (biopsy tissue obtained)
H\&E slides from passes 1, 2, and 3 will be reviewed. The amount of blood present on each H\&E slide will be quantified by using image processing software (blood contamination area between passes).
次要结局
- Cellularity Captured in Successive Fine Needle Biopsies Saline Group(Day 1 (biopsy tissue obtained))
- Blood Contamination in Successive Fine Needle Biopsies Saline Group(Day 1 (biopsy tissue obtained))
- Participants Who Needed Repeated Endoscopic Ultrasound (EUS) Biopsy(4 weeks (after initial biopsy))
研究者
Jorge Machicado, MD, MPH
Assistant Professor of Internal Medicine
University of Michigan