Diagnostic Accuracy of FNA (Fine Needle Aspiration) on Solid Pancreatic Lesions: is Aspiration- Related?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- sample adequacy
研究概览
简要总结
BACKGROUND: EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic masses. Different needle diameters and the use of stylet are not associated with differences in terms of diagnostic yield for malignancy. Preliminary studies showed that using suction (10ml) is associated with a higher sensitivity for cancer diagnosis. We aim to compare EUS-FNA in the same solid pancreatic mass performed with the 22 gauge needle with different aspiration volumes (10, 20, 0ml), looking for adequacy, diagnostic accuracy and complications.
METHODS: Prospective clinical study at four referral Centers: ISMETT Palermo; Bellaria-Maggiore, Bologna; Civico-A.R.N.A.S, Palermo; Humanitas-IRCCS, Rozzano. EUS was performed by five experienced echo-endoscopist. The needle system was in all cases the 22 gauge EUS-FNA(Expect). We performed three punctures with a 22 G needle with both volume aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no aspiration) was randomly assigned by sealed envelope system. For each pass tissue samples were smeared into slides for ROSE(Rapid-On-Site-Evaluation); after smearing sample into the slides, the material was fixed in formalin for cyto-histological evaluation. The cyto-pathologist was always blinded as to which aspiration was used for which specimen. After EUS-FNA the patients were monitored for at least six hour to detect immediately post-procedural complication and were followed up during the 30 days post-procedure in order to detect late complications.
详细描述
Background
EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic masses [ASGE Practice Committee] with high sensitivity and specificity (75-92% - 82-100%), [1-2-3] and low complication rate (1-2%) [4-5-6]. In the clinical setting of solid pancreatic mass a histological diagnosis appears highly relevant both for differential diagnosis (adenocarcinoma, lymphoma or neuroendocrine tumour) and for optimal therapeutic decision. For the cythopathologic diagnosis of pancreatic cancer, sensitivity increased with the operator's experience and reached 80% after 20 to 30 EUS-FNA. Furthermore it well demonstrated that on-site cytopathology interpretation during the procedure increase the diagnostic yield of EUS-FNA [7-8]. ROSE (Rapid On -Site Evaluation) may be useful to guide the number of FNA passes, learn which parts of the lesion may be targeted for increased diagnostic yield, and correct technical errors (e. g. bloody or paucicellular material) [9, 10]. The diagnostic yield of EUS-guided biopsies depends on size, location and characteristics of target tissues as well as on technical and procedural factors (type of needle, biopsy technique and material processing) [11-20].
Expertise and training of endosonographer and interaction with the cytopathologist have also an important role [7-14-15]. Up to now three different sizes of needle are available for collecting cytological material: 25 - 22 and 19 gauge with an aspiration volume syringe of 10ml. Most of the studies on EUS-FNA have been conducted using 22G needles. Data on thinner (25G) or larger (19G) needles are limited. A number of recent studies, including two RCTs, compared results obtained with needles of various diameters. All these studies were performed in the setting of pancreatic masses [18-20]. Although thinner needles provide less cellular material than do larger needles, the specimens from the former are less contaminated by blood, and thus easier to interpret. In addition, thinner needles may be easier to use because of greater flexibility, particularly for locations requiring important scope bending [18, 19]. An RCT in 131 patients found no significant differences between 22G and 25G needles in terms of diagnostic yield for malignancy [17]. Finally another RCT compared EUS-FNA without ROSE using 19G or 22G needles in 117 patients [18] showed a similar diagnostic accuracy for both needles.
If the diameter of the needle used does not appear to affect the diagnostic accuracy of FNA on solid pancreatic lesions, preliminary studies show that using suction during EUS FNA of solid masses is associated with a significantly higher sensitivity for cancer diagnosis (86% vs. 67%; P=0.05) [20]. A pilot trial suggested that applying continuous high pressure suction (using a balloon inflation device) allowed retrieval of tissue samples for histopathological examination in most cases [21].
A new needle Expect by Boston Scientific are available with an aspiration syringe with variable volume of 5-10-15-20cc. No studies were performed comparing the diagnostic yield of FNA on solid pancreatic masses performed with different aspiration volume (10 and 20ml) and without aspiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed or suspected solid pancreatic lesions according to imaging (CT-scan or/and MRI);
- •no contraindications for FNA (see
排除标准
- •Exclusion Criteria:
- •age < 18 years;
- •cystic pancreatic lesions;
- •history of previous gastrectomy;
- •patients hemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 60.000 cells/cubic millimetre [cmm3]);
- •patients unable to suspend anticoagulant therapy;
- •pregnancy;
- •inability to give informed consent;
- •refusal to participate to the study.
结局指标
主要结局
sample adequacy
时间窗: 20min
Tissue samples was immediately smeared into slides after each puncture, fixed and all the prepared slides will be viewed by experienced pathologists for ROSE (Rapid On Site Evaluation). For each pass, after smearing sample into the slides, the material was fixed in formalin for cyto histological evaluation. The cytopathologist was always blinded as to which aspiration was used for which specimen.
次要结局
- diagnostic accuracy(5 days)