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临床试验/NCT05041335
NCT05041335尚未招募不适用

Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB) of Solid Abdominal Masses: A Randomized Prospective Trial

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
试验地点
2
主要终点
Aggregate specimen length (ASL)

研究概览

简要总结

The purpose of this research is to compare the amount and quality of tissue obtained by EUS-FNB when the device is flushed with an anticoagulant or "blood thinner" vs. saline a salt water solution as well as the use of a microsieve in order for the doctor to look at the tissue to check the acceptability of the specimens before sending for analysis.

You will be randomly assigned (like a flip of a coin) to have either the blood thinner or the salt water solution placed within the needle being used to sample your abdominal tumor and to have either a sieve used or not.

You will be one of 42 participants enrolled in this data collection study which includes 1 sites in the United States.

详细描述

Since its inception in the early 1990's, endoscopic ultrasound with fine needle aspiration (EUS-FNA) has developed into an important method for obtaining diagnostically accuracy for gastrointestinal, and extra-luminal pathology [1,2]. Present society guidelines by both the European Society of Gastrointestinal Endoscopy (ESGE) and American Society of Gastrointestinal Endoscopy (ASGE) have estimated an overall 60-90% diagnostic accuracy of EUS-FNA [2,3]. However, this accuracy is dependent upon determination of adequacy by expert gastrointestinal pathologists, which may not be available at all centers [4-6].

New developments in needle technology has led to development of "core needles", which can allow for acquisition of a tissue specimen with intact tissue architecture and therefore more ability for immunohistochemical staining (IHC). When evaluating pancreatic lesions, FNB needles have demonstrated 81-100% technical success and up to 94.7% diagnostic accuracy [18-21]. Overall, EUS-FNB appears to be a promising addition to EUS guided tissue acquisition, which has the potential of leading to improved diagnostic accuracy.

As an additional means for optimizing EUS-FNB, heparin has been described and studied in the past. The study investigators have been using heparin to prime the wet suction needle to prevent formation of clot in the needle which produces "blood noodles" in the specimen that can interfere with tissue processing and interpretation. There are previous data demonstrating that heparin priming of the needle may also increase yield [22]. The study investigators have demonstrated that use of a heparin primed needle does not interfere with cytology, histology or immunohistochemical analysis, and may ease stylet handling [23]. Also, the study investigators have directly validated the use of heparin for EUS-guided liver biopsies (EUS-LB) demonstrating improvement in the size and number of histologic fragments obtained from EUS-guided biopsy [24-25]. Given this information, heparin flush is actively used and readily available, in EUS-guided biopsies here at UH.

Rapid onsite cytological evaluation (ROSE) has been used to make an immediate assessment of tissue adequacy during the EUS-FNA procedure, as well as to deliver a rapid pathological diagnosis during the EUS session. ROSE has been shown to increase the yield while having the potential of decreasing the number of needle passes required. However, ROSE is not available at many EUS centers. It would be advantageous to predict adequacy of a needle biopsy specimen without having to rely on ROSE.

In standard EUS-FNA practice, part of the biopsy specimens is used to prepare a smear that can be examined microscopically. The remainder of the specimen processed by the laboratory for "cell block" analysis. Microscopic examination of the smears and the cell-block are done by the pathologist to arrive at a final diagnosis.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

These needle preparations will be wrapped in non-transparent 2-inch tape to hide the appearance of the injectate agent. The needle is prepared by removing the stylet and flushing with the selected substance. The PI/Co-I will then flush the needle with the selected substance until drops of the liquid are seen exiting the needle tip. Those randomized to have the needle flushed with heparin will be termed "dry heparin" and will be flushed with 500 U heparin USP per 10 mL. Those who randomize not to receive heparin, the needle will be flushed with saline. The device shall then be placed into the linear echoendoscope and the FNB will be performed. The PI is blinded to heparin vs. no heparin only. Randomization to the microsieve vs. not is apparent to the PI.

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

  • Age ≥ 18 year
  • Non-pregnant Patients
  • Patients with the presence of a solid abdominal mass as seen on diagnostic imaging [ie. ultrasound (US), computer tomography (CT) or magnetic resonance imaging (MRI)] scheduled to undergo EUS examination OR Patients who underwent a prior EUS-FNA/FNB for solid pancreatic mass and did not receive a conclusive diagnosis
  • Patients with platelet count > 50,000
  • Patients with International Normalized Ratio (INR) < 1.5

排除标准

  • Age < 18 years
  • Pregnant Patients
  • Patients who cannot consent for themselves
  • Patients with anticoagulants or anti-platelet agents (excluding aspirin) within the last 7-10 days
  • Patients with cystic abdominal masses
  • Patients with a platelet count < 50,000
  • Patients with an INR > 1.5
  • Patients with a heparin or porcine allergy
  • Patients with prior heparin induced thrombocytopenia (HIT)
  • Patient's with religious aversion to porcine-containing products

结局指标

主要结局

Aggregate specimen length (ASL)

时间窗: immediately after the intervention/procedure/surgery

sum length of all pieces of tissue obtained from EUS-FNB

次要结局

  • Mean number of small pieces(immediately after the intervention/procedure/surgery)
  • Mean blood clot score during histology(immediately after the intervention/procedure/surgery)
  • Mean number of medium pieces(immediately after the intervention/procedure/surgery)
  • Length of the longest piece (LLP)(immediately after the intervention/procedure/surgery)
  • Means number of long pieces(immediately after the intervention/procedure/surgery)
  • Presence of a visible core specimen(immediately after the intervention/procedure/surgery)
  • Histology adequacy score(immediately after the intervention/procedure/surgery)
  • Presence of visible clots in specimen(immediately after the intervention/procedure/surgery)
  • Adequacy of diagnosis(immediately after the intervention/procedure/surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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