FNA Needle Research Articles

Residual contamination and bioburden after reprocessing of single‐use endoscopic ultrasound needles: An ex vivo study

Endoscopic ultrasound (EUS) aspiration needles are single-use devices. However, in many centers, because of cost-constraints, these devices are reused multiple times. We studied microbiological contamination and bioburden on reprocessed needles to evaluate whether these devices can be successfully sterilized. We studied 10 EUS needles each of 19G, 22G, and 25G in size, and five 22-G ProCore needles. After initial use, each needle was reprocessed by a standardized protocol. We used standard microbiological cultures, as well as ATP bioluminescence technique to quantify bioburden as relative light units (RLU). We defined significant soil contamination by RLU values >200. We also used extractant fluid to disrupt cell membranes in an attempt to enhance ATP detection. We found culture positivity in 3/34 (8.8%), and detectable bioburden on the exposed surface of 33/35 (94.3%), and inside lumen of 29 (82.9%) reprocessed FNA needles. Significant bioburden was found in three (8.6%) and two (5.7%) needles on the surface and lumen, respectively. We found that use of extractant fluid enhanced detection of bioburden. Larger (19G) needles had higher surface contamination (P=0.016), but there was no relation of luminal contamination with needle diameter (P=0.138). Sheath design and presence of side bevel did not influence extent of contamination. There was significant correlation between the surface and intraluminal bioburden (P<0.001). There is significant bioburden in reprocessed EUS needles; standard microbiological cultures have low sensitivity for detection of needle contamination. We have provided objective evidence for the futility of reprocessing attempts, and practice of EUS needle reuse should be discontinued.

New and Improved: Our Experience with the 22G Cook Fiducial Needle System

Traditionally fiducial markers have served as reference points and have been placed by Endoscopic ultrasound (EUS), intraoperatively, or percutaneously via ultrasound or CT. EUS guided placement has increased in popularity recently due to the ability of EUS to allow for close proximity to deeper abdominal structures not easily accessible via surgical or percutaneous routes. One limitation to the growth of this technique has been the need to individually back load and seal the fiducial using bone wax or recently described wet fill technique. The back loading procedure increases the time for the procedure, may increase risk to the operator if one is loading fiducials into dirty needles (when more than one fiducial is required), or increase cost if new FNA needles are used for each fiducial. The new 22G Cook Fiducial needle is preloaded with four gold fiducials, which solves many of the problems mentioned. Four patients underwent fiducial placement with the 22G Cook Fiducial Needle System. A 63 year old male with metastatic renal cell carcinoma to the stomach and proximal duodenum presented with melena. EGD showed a large ulcerated bleeding mass in the anterior wall of the stomach. Fiducials were placed to allow for selective embolization. A 52 year old male presented with progressive dysphagia and weight loss. EGD revealed a large partially obstructing lower esophageal mass. Pathology confirmed esophageal adenocarcinoma and he underwent fiducial placement to assist in intensity modulated neoadjuvant radiation therapy. A 68 year old male with rectal adenocarcinoma had a 10 mm mass in the left lobe of the liver. The patient was to undergo neo-adjuvant therapy followed by surgical resection of the primary tumor and wedge resection of the solitary liver lesion. Fiducial placement was requested prior to neoadjuvant therapy to mark the position of the mass for localization during the eventual wedge resection. A 57 year old male with abdominal pain had an EUS which showed an ill-defined mass in the pancreatic neck with background chronic pancreatitis. EUS FNA of the mass was positive for adenocarcinoma. Due to ill-defined nature of the mass, the presence of background chronic pancreatitis and for accurate surgical localization fiducial placement was requested. We have shown that this needle is easy and quick to use in a variety of settings with subsequent excellent visualization of the fiducial with no immediate or delayed complications.

Optimizing EUS-guided liver biopsy sampling: comprehensive assessment of needle types and tissue acquisition techniques

EUS-guided liver biopsy sampling using FNA and, more recently, fine-needle biopsy (FNB) needles has been reported with discrepant diagnostic accuracy, in part due to differences in methodology. We aimed to compare liver histologic yields of 4 EUS-based needles and 2 percutaneous needles to identify optimal number of needle passes and suction. Six needle types were tested on human cadaveric tissue: one 19G FNA needle, one existing 19G FNB needle, one novel 19G FNB needle, one 22G FNB needle, and two 18G percutaneous needles (18G1 and 18G2). Two needle excursion patterns (1 vs 3 fanning passes) were performed on all EUS needles. Primary outcome was number of portal tracts. Secondary outcomes were degree of fragmentation and specimen adequacy. Pairwise comparisons were performed using t tests, with a 2-sided P< .05 considered to be significant. Multivariable regression analysis was performed. In total, 288 liver biopsy samplings (48 per needle type) were performed. The novel 19G FNB needle had significantly increased mean portal tracts compared with all needle types. The 22G FNB needle had significantly increased portal tracts compared with the 18G1 needle (3.8 vs 2.5, P< .001) and was not statistically different from the 18G2 needle (3.8 vs 3.5, P= .68). FNB needles (P< .001) and 3 fanning passes (P≤ .001) were independent predictors of the number of portal tracts. A novel 19G EUS-guided liver biopsy needle provides superior histologic yield compared with 18G percutaneous needles and existing 19G FNA and core needles. Moreover, the 22G FNB needle may be adequate for liver biopsy sampling. Investigations are underway to determine whether these results can be replicated in a clinical setting.

EUS-guided intrahepatic portosystemic shunt with direct portal pressure measurements: a novel alternative to transjugular intrahepatic portosystemic shunting

Transjugular intrahepatic portosystemic shunting involves the creation of a low-resistance channel between the portal vein (PV) and the hepatic vein (HV), and is routinely performed under angiography. The aims were to evaluate (1) safety and technical feasibility; (2) procedural duration; and (3) subjective workload assessment of EUS-guided intrahepatic portosystemic shunt (EIPS). Five Yorkshire pigs were used in the study. The HV or inferior vena cava (IVC) was identified using a linear-array echoendoscope and accessed with a 19-G FNA needle preloaded with a digital pressure wire. Mean pressure was recorded. The needle was advanced into the PV, where pressure measurements were again taken, and ultimately exchanged over a guidewire. A lumen-apposing metal stent was deployed under EUS and fluoroscopic guidance, with distal and proximal ends positioned inside the PV and HV (IVC),respectively. Dilation was performed, and pressure measurements repeated. The National Aeronautics and Space Administration (NASA) Task Load Index (TLI) was scored. Animals survived 2 weeks before necropsy. EIPS was successful in 5 out of 5 pigs. Mean time required for EUS identification, needle access, pressure measurement, and stent placement was 43 (31-55) minutes. NASA TLI scores revealed moderate workload. Mean baseline pressure measurements were PV 7.0 (5-9) and HV/IVC 5.0 (3-7)mm Hg and PV 6.3 (5-7) and HV/IVC 6.0 (4-7)mm Hg after. All animals survived 2 weeks. No bleeding was seen on necropsy. This study demonstrates the technical feasibility of EIPS using LAMS, with direct portal pressure measurement, in a survival model. In addition, the procedure was performed quickly with moderate technical demand.

Impact of EUS-guided fine-needle biopsy sampling with a new core needle on the need for onsite cytopathologic assessment: a preliminary study.

FNA is the primary method of EUS tissue acquisition. In an attempt to improve our yield of EUS-guided tissue acquisition, we compared fine-needle biopsy (FNB) sampling without rapid onsite evaluation (ROSE) with FNA with ROSE and assessed the concordance of FNA and FNB sampling. This was a retrospective review of prospectively collected data from consecutive patients. Patients underwent FNB sampling and FNA of the same single lesion, with the same needle gauge and number of passes. FNA with ROSE was performed with a standard FNA needle. FNB sampling was performed with a new dedicated core needle. FNA samples were assessed with ROSE, and a final interpretation was provided by cytopathology staff; FNB samples were analyzed by surgical pathologists, each not made aware of the other's opinion. Thirty-three patients underwent 312 passes in 42 different lesions. A diagnosis of malignancy was more likely with FNB sampling than with FNA (72.7% vs 66.7%, P= .727), although statistical significance was not reached. FNA and FNB sampling had similar sensitivities, specificities, and accuracies for cancer (81.5% vs 88.9%, 100% vs 100%, and 84.8% vs 90.9%, respectively). FNB sampling provided qualitative information not reported on FNA, such as degree of differentiation in malignancy, metastatic origin, and rate of proliferation in neuroendocrine tumors. FNB sampling without ROSE using a dedicated core needle performed as well as FNA with ROSE in this small cohort, suggesting that FNB sampling with this new core needle may eliminate the need for an onsite cytopathologic assessment, without loss of diagnostic accuracy.

Endoscopic Ultrasound : A New Hope for Patients

Endoscopic Ultrasound (EUS) combines endoscopic view and ultrasound images to obtain information about the gastrointestinal tract and the surrounding tissues and organs in abdomen and mediastinum. Placing the transducer on the tip of an endoscope allows it to get close to the organs inside the body. The EUS can also obtain information about the layers of the intestinal wall as well as adjacent areas such as lymph nodes and the blood vessels. It can study the flow of blood inside blood vessels using Doppler ultrasound and obtain tissue samples by passing a FNA needle into enlarged lymph nodes or suspicious tumors. Staging of cancer is becoming an important use of EUS. It can provide information regarding the depth of penetration and spread of cancer to adjacent tissues and lymph nodes, useful for staging. Interventional EUS offers durable analgesia for palliation and minimally invasive drainage procedures which does not result in cutaneous fistulae. In future, Interventional EUS will open up a new frontier hence further improving the contributory role of GI endoscopy. Our aim was to evaluate the role of endoscopic ultrasound (EUS) in literatures of the past 3 decades as diagnostic and therapeutic aid based on original articles (randomized controlled trials, prospective and retrospective studies), meta-analyses, reviews and surveys pertinent to gastrointestinal EUS. MEDLINE and PubMed search (1984-2013) were conducted using ‘Endoscopic Ultrasound’ for re-trieving pertinent studies and arranged according to equipment introduction, uses, procedures, advantage, disadvantage, complications,, therapeutic applications and limitations of EUS. Figures included are taken during performance of the EUS procedures at the institute.J Bangladesh Coll Phys Surg 2015; 33(1): 23-31

PTU-043 Prospective Study of the Diagnostic Yield from Histological Versus Cytological Preparation of Specimens Acquired Using Standard EUS FNA Needles

Introduction Improvements in the EUS FNA needle design and optimisation of tissue acquisition techniques have resulted in better diagnostic yield (DY). Recently there has been considerable interest in histological processing of tissue acquired using newer ‘core’ FNA needles, which are often more expensive than standard needles. We hereby provide preliminary data on DY of tissue acquired using standard FNA needles. Aim To compare the diagnostic yield of histological versus cytological preparation of tissue acquired using standard EUS FNA needle and to compare overall diagnostic yield. Methods Prospective non-blinded randomised study . All patients undergoing EUS guided FNA from November 2015 to February 2016, for solid lesions were included. FNA was performed using Cook Echotip Ultra TM or Boston Scientific Expect TM 19, 22 or 25 G needles based on stock availability and location of the lesion, Olympus EU-ME2 TM processor and linear echoendoscopes was used. All patients had 4 passes done with the same needle, specimens from each pass were randomly collected in BD Cytorich TM or Formalin. Each preservative had 2 passes of material. EUS FNA was performed by one endosonographer and two trainees employing standard FNA technique and suction, pathology reported by 5 different cytopathologists. All cytology specimens were processed by the biomedical scientists for cell block ± smear preperation. Cellularity of the sample were simply graded as adequate or inadequate. Histology processing was performed as standard. Results In total 21 patients had EUS FNA performed, mean age 65.5±12.1 years, 14 M:7 F. Final diagnoses include 5 pancreatic malignancies, 5 GIST/NET, 2 malignant nodes, 1 lymphoma, 6 benign, 2 non-diagnostic. 19 G needle was used in 15 patients, 22 G in 4 patients and 25 G in 2 patients. Diagnosis was made in 15/21 (71.4%) from cytology specimens and 19/21 (90.4%) from combined cytology and histologically processed specimens. An incremental diagnostic gain in 4/21 specimens, i.e. 19% by processing samples as histology in addition to standard cytology. No statistical significance was seen on univariate or multivariate logistic regression analysis for tumour size (≥2 cm), route of FNA or size of needle. Limitations of the study include small sample size, no blinding being used for randomisation of the FNA specimen. Conclusion Our ‘proof of concept’ study with preliminary results show that adequate samples can be obtained for histological processing even with standard FNA needles and incremental gain in DY by additionally processing specimens as histology. Data from our randomised blinded trial would shed further light into this important area. Disclosure of Interest None Declared

Endoscopic ultrasound fine-needle aspiration vs. fine-needle biopsy: tissue is always the issue.

Endoscopic ultrasound fine-needle aspiration vs. fine-needle biopsy: tissue is always the issue.

EUS-guided portal pressure gradient measurement with a novel 25-gauge needle device versus standard transjugular approach: a comparison animal study

Portal hypertension (PH) is a serious adverse event of liver cirrhosis. The hepatic venous pressure gradient (HVPG) accurately reflects the degree of PH and is the single best prognostic factor in liver disease. Currently, portal pressure gradient (PPG) measurement is performed at interventional radiology (IR) with a standard transjugular approach requiring radiation and intravenous contrast. The aim of this study was to develop a novel EUS-guided system using a 25G FNA needle and compact manometer to directly measure PPG and to evaluate its performance and clinical feasibility. Experiments were performed in 3 swine that were under general anesthesia. Manometry was performed in venous (baseline and PH) and arterial (aorta) systems. The PH model was created by rapid Dextran-40 infusion peripherally. Under EUS guidance a 25G FNA needle with attached manometer was used to puncture (transgastric-transhepatic approach) and measure pressures in the portal vein, right hepatic vein (RHV), inferior vena cava (IVC), and aorta. With the IR approach, RHV (free and wedged), IVC, and aorta pressure were measured with an occlusion balloon. Pressure correlation was divided into 3 groups; low pressure (baseline), medium pressure (noncirrhotic portal hypertensive model), and high pressure (arterial). Correlation between the 2 methods of measurement was charted in scatter plots, and the Pearson's correlation coefficient (R) was calculated. EUS identification, access, and manometry was successful in all targeted vessels. There was excellent correlation (R, .985-.99) between EUS and IR methods in all pressure ranges. No adverse event occurred. This novel technique of EUS-PPG measurement using a 25G needle and novel manometer was feasible and demonstrated excellent correlation with the standard transjugular method throughout low, medium, and high pressure ranges.

Abstract OT2-02-02: NRG Oncology/NSABP B-51/RTOG 1304: A phase III clinical trial to determine if chest wall and regional nodal radiotherapy (CWRNRT) post mastectomy (Mx) or the addition of RNRT to breast RT post breast-conserving surgery (BCS) will reduce invasive cancer events in patients (pts) with positive axillary (Ax) nodes who are ypN0 after neoadjuvant chemotherapy (NC)

Abstract Background: This phase III post-NC trial will evaluate if CWRNRT post Mx or whole breast irradiation (WBI) with RNRT after BCS significantly reduces the invasive breast cancer recurrence-free interval (IBC-RFI) rate in pts presenting with positive Ax nodes that are negative after NC. Secondary aims are OS, LRRFI, DRFI, DFS-DCIS, and second primary cancer as well as comparing RT effect on cosmesis in reconstructed Mx pts. Correlative science examines RT effect by tumor subtype, molecular outcome predictors for residual disease pts, and predictors for the degree of reduction in loco-regional recurrence. Methods: Clinical T1-3, N1 IBC pts with positive Ax nodes (FNA or core needle biopsy) complete ≥12 wks of NC (anthracycline and/or taxane). HER2-positive pts receive anti-HER2 therapy (tx). After NC BCS or Mx is performed with a sentinel node biopsy (≥3 nodes) and/or Ax dissection with histologically negative nodes. ER/PR and HER-2 neu status before NC is required. Pts receive required systemic tx. Radiation credentialing with a facility questionnaire and a case benchmark is required. Randomization for Mx pts is to no CWRNRT or CWRNRT and for BCS pts to WBI or WBI RNRT. Statistics: 1,636 pts to be enrolled over 5 yrs with definitive analysis at 7.5 yrs. Study is powered at 80% to test that RT reduces the annual hazard rate of events for IBCR-FI by 35% for an absolute risk reduction in the 5-yr cumulative rate of 4.6%. Intent-to-treat analysis with 3 interim analyses at 43, 86, and 129 events, with a 4th/final analysis at 172 events will occur. Accrual as of 6/4/15 is 143. Pt-reported outcomes focusing on RT effect will be provided by 736 pts before randomization and at 3, 6, 12, and 24 months. Contacts: Protocol: CTSU member website https://www.ctsu.org. Questions: NRG Oncology Pgh Clin Coord Dpt: 1-800-477-7227 or ccd@nsabp.org. Pt entry: OPEN at https://open.ctsu.org or the OPEN tab on CTSU member website. Support: U10 CA-2166; -180868, -180822; -189867; Elekta. Citation Format: Mamounas EP, Bandos H, White JR, Julian TB, Khan AJ, Shaitelman SF, Torres MA, Vicini FA, Ganz PA, McCloskey SA, Paik S, Gupta N, Li XA, DiCostanzo DJ, Costantino JP, Curran Jr WJ, Wolmark N. NRG Oncology/NSABP B-51/RTOG 1304: A phase III clinical trial to determine if chest wall and regional nodal radiotherapy (CWRNRT) post mastectomy (Mx) or the addition of RNRT to breast RT post breast-conserving surgery (BCS) will reduce invasive cancer events in patients (pts) with positive axillary (Ax) nodes who are ypN0 after neoadjuvant chemotherapy (NC). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT2-02-02.

EUS Needle Identification Comparison and Evaluation study (with videos)

EUS-guided FNA or biopsy sampling is widely practiced. Optimal sonographic visualization of the needle is critical for image-guided interventions. Of the several commercially available needles, bench-top testing and direct comparison of these needles have not been done to reveal their inherent echogenicity. The aims are to provide bench-top data that can be used to guide clinical applications and to promote future device research and development. Descriptive bench-top testing and comparison of 8 commonly used EUS-FNA needles (all size 22 gauge): SonoTip Pro Control (Medi-Globe); Expect Slimline (Boston Scientific); EchoTip, EchoTip Ultra, EchoTip ProCore High Definition (Cook Medical); ClearView (Conmed); EZ Shot 2 (Olympus); and BNX (Beacon Endoscopic), and 2 new prototype needles, SonoCoat (Medi-Globe), coated by echogenic polymers made by Encapson. Blinded evaluation of standardized and unedited videos by 43 EUS endoscopists and 17 radiologists specialized in GI US examination who were unfamiliar with EUS needle devices. There was no significant difference in the ratings and rankings of these needles between endosonographers and radiologists. Overall, 1 prototype needle was rated as the best, ranking 10% to 40% higher than all other needles (P< .01). Among the commercially available needles, the EchoTip Ultra needle and the ClearView needle were top choices. The EZ Shot 2 needle was ranked statistically lower than other needles (30%-75% worse, P< .001). All FNA needles have their inherent and different echogenicities, and these differences are similarly recognized by EUS endoscopists and radiologists. Needles with polymeric coating from the entire shaft to the needle tip may offer better echogenicity.

A pilot study of EUS-guided through-the-needle forceps biopsy (with video)

In EUS-guided FNA (EUS-FNA), small-caliber needles are preferable for optimal cytologic yield, whereas large ones are preferable when histologic specimens are needed. Because of the rigidity and friction induced by its large caliber, however, technical limitation does exist in a 19-gauge FNA needle. Recent development of miniature biopsy forceps enables EUS-guided through-the-needle forceps biopsy (EUS-TTNFB). The aim of this study is to evaluate safety and efficacy of EUS-TTNFB. Eighteen sessions of EUS-TTNFB in 17 patients with solid lesions were performed by using a 0.75-mm biopsy forceps through a 19-gauge FNA needle. Technical feasibility, safety, and diagnostic yield of EUS-TTNFB were retrospectively studied. A total of 49 passes, a median of 3 passes per session, were performed, and the needle puncture, advancement and removal of the biopsy forceps, and subsequent EUS-FNA were technically successful in all patients. No adverse events were observed other than one case with hyperamylasemia without pancreatitis. Macroscopic histologic core by EUS-TTNFB was obtained at a rate of 71% per pass. The tissue acquisition rate by EUS-TTNFB alone was 67% per pass and 100% per session. When EUS-TTNFB and subsequent EUS-FNA were combined, the tissue acquisition rate was 94% per pass. The accuracy of combined EUS-TTNFB and EUS-FNA to diagnose malignancy was 88% per pass and 94% per session. With a single pass of EUS-TTNFB and EUS-FNA, the tissue acquisition rate was 89%, and the accuracy to diagnose malignancy was 83%. EUS-TTNFB was safe and technically feasible and provided additional tissue acquisition with a single puncture of a 19-gauge FNA needle.

Role of endoscopy in the diagnosis of autoimmune pancreatitis and immunoglobulin G4 - Related sclerosing cholangitis

Autoimmune pancreatitis (AIP) must be differentiated from pancreatic carcinoma, and immunoglobulin (Ig)G4-related sclerosing cholangitis (SC) from cholangiocarcinoma and primary sclerosing cholangitis (PSC). Pancreatographic findings such as a long narrowing of the main pancreatic duct, lack of upstream dilatation, skipped narrowed lesions, and side branches arising from the narrowed portion suggest AIP rather than pancreatic carcinoma. Cholangiographic findings for PSC, including band-like stricture, beaded or pruned-tree appearance, or diverticulum-like outpouching are rarely observed in IgG4-SC patients, whereas dilatation after a long stricture of the bile duct is common in IgG4-SC. Transpapillary biopsy for bile duct stricture is useful to rule out cholangiocarcinoma and to support the diagnosis of IgG4-SC with IgG4-immunostaining. IgG4-immunostaining of biopsy specimens from the major papilla advances a diagnosis of AIP. Contrast-enhanced endoscopic ultrasonography (EUS) and EUS elastography have the potential to predict the histological nature of the lesions. Intraductal ultrasonographic finding of wall thickening in the non-stenotic bile duct on cholangiography is useful for distinguishing IgG4-SC from cholangiocarcinoma. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is widely used to exclude pancreatic carcinoma. To obtain adequate tissue samples for the histological diagnosis of AIP, EUS-Tru-cut biopsy or EUS-FNA using a 19-gauge needle is recommended, but EUS-FNA with a 22-gauge needle can also provide sufficient histological samples with careful sample processing after collection and rapid motion of the FNA needles within the pancreas. Validation of endoscopic imaging criteria and new techniques or devices to increase the diagnostic yield of endoscopic tissue sampling should be developed.

Pathologic evaluation of a new endoscopic ultrasound needle designed to obtain core tissue samples: A pilot study.

Background and Objectives:Standard endoscopic ultrasound-fine-needle aspiration (EUS-FNA) needles are in widespread use. Meaningful differences between the available needles have been difficult to identify. Recently, a new EUS needle (Shark Core®, Covidien, Dublin, Leinster, Ireland), has been introduced in an attempt to improve diagnostic accuracy, tissue yield, and to potentially obtain a core tissue sample. We performed a pilot study prospectively to evaluate this new needle when compared to a standard EUS-FNA needle.Materials and Methods:Analysis of the first 15 patients undergoing EUS-FNA with the Shark Core needle was performed and it was compared to EUS-FNA in 15 patients who underwent EUS-FNA with a standard needle.Results:The Shark Core needle required fewer needle passes to obtain diagnostic adequacy than the standard needle [(χ2(1) = 11.3, P < 0.001]. The Shark Core needle required 1.5 passes to reach adequacy, whereas the standard needle required three passes. For cases with cell blocks, the Shark Core needle produced diagnostic material in 85% of cases [95% confidence interval (CI): 54–98], whereas the standard needle produced diagnostic material in 38% of the cases (95% CI: 9-76). The Shark Core needle produced actual tissue cores 82% of the time (95% CI: 48–98) and the standard needle produced no tissue cores (95% CI: 0-71) (P = 0.03).Conclusion:This pilot study found that the Shark Core needle had a high rate of producing adequate cytologic material for the diagnosis of pancreatic and peri-pancreatic lesions sampled by EUS with fewer passes required to obtain a definitive diagnosis and with a high rate of tissue cores being obtained when compared to a standard FNA needle.

EUS-guided portal pressure measurement using a digital pressure wire with real-time remote display: a novel, minimally invasive technique for direct measurement in an animal model

Hepatic venous pressure gradient (HVPG) currently serves as a surrogate for portal pressure measurement but has many limitations. We developed a novel technique for rapid and direct portal pressure measurements using a digital pressure wire delivered through an EUS-guided 22-gauge FNA needle. Our aims were to evaluate (1) the short-term safety and technical feasibility, (2) procedural duration and subjective workload assessment, and (3) accuracy compared with a transjugular criterion standard approach. The subjects were Yorkshire pigs, weighing 40 to 55 kg. The portal vein was identified by using a linear array echoendoscope and accessed with a commercially available 22-gauge FNA needle preloaded with a digital pressure wire. Access was confirmed by portal venography. Mean digital pressure measurements were recorded over 30 to 60 seconds, and the National Aeronautics and Space Administration Task Load Index was scored. The control measurements were conventional transjugular catheterization with a balloon occlusion catheter to obtain free and wedged hepatic pressures, with subsequent HVPG calculation. The total time required for EUS identification and needle access of the portal vein, venography, and digital pressure measurement was less than 5 minutes in 5 of 5 pigs. The National Aeronautics and Space Administration Task Load Index scores revealed a low subjective workload. Baseline portal pressure measurements via EUS ranged from 5 mm Hg to 10 mm Hg (mean, 6.4 mm Hg). HVPG measurements were consistently ±1 mm Hg of portal pressure. This study is the first report of direct EUS-guided portal pressure measurements by using a digital pressure wire. This method is routinely performed in minutes and provides real-time pressure tracings via wireless transmission. This novel approach for direct portal pressure measurement has the potential to replace traditional indirect HVPG measurements.

Adequacy Assessment of Thyroid FNA Needle Rinse Specimens for Molecular Testing: An Institutional Experience

Adequacy Assessment of Thyroid FNA Needle Rinse Specimens for Molecular Testing: An Institutional Experience

Endoscopic Ultrasound-Guided Portal Pressure Gradient (PPG) Measurement: A Simplified Novel Technique Using 25-Gauge FNA Needle With Compact Transducer Versus Standard Transjugular Approach: A Comparative Animal Study: Presidential Poster

Introduction: Portal hypertension (PH) is a serious complication of liver cirrhosis. The hepatic venous pressure gradient (HVPG) accurately reflects the degree of PH and is the single best prognostic factor in liver disease. HVPG can guide medical therapy and predict liver decompensation as well as cancer risk. Currently, measurement of PPG is performed using an invasive transjugular approach requiring radiation and IV contrast; and it provides only an indirect measurement. We present the first study of a novel, simple EUS-guided system using a 25g FNA needle and compact manometer to directly measure PPG with simultaneous comparison to the standard transjugular method. Methods: Experiments were performed in 3 swine under general anesthesia. Baseline and portal hypertensive venous manometry was performed. The PH model was created by rapid Dextran-40 infusion. Using a linear echoendoscope, a 25g FNA needle with attached manometer was used to puncture (transgastric-transhepatic approach) and measure pressures in the portal vein (PV), right hepatic vein (RHV), and inferior vena cava (IVC). Pressure measurements in the aorta were also performed. Manometric data was obtained from the RHV (free and wedged), IVC and aorta with an occlusion balloon. All EUS and transjugular manometric data were captured simultaneously, in real time, at each corresponding vessel. Pressure correlation was divided into three groups; low pressure (baseline), medium pressure (PH model) and high pressure (arterial). Scatter plots and Pearson's correlation coefficient (R) were used. Results: EUS identification, access and manometry were successful in all targeted vessels. There was excellent correlation between EUS and transjugular approach at all pressure ranges. R co-efficient was 0.99 (Arterial, venous-graph 1), 0.986 (all veins-graph 2) and 0.985 (PV+HV only-graph 3). No adverse event occurred despite repeated vascular punctures. No bleeding was seen at EUS or on fluoroscopy, despite presence of PH. Necropsy was not performed.Figure 1Figure 2Figure 3Conclusion: This novel technique of EUS-PPG measurement using a 25G needle and novel manometer was feasible and demonstrated excellent correlation with the standard transjugular method throughout low, medium and high pressure ranges. There were no adverse events acutely. Clinical trials are currently underway.

Endoscopic Ultrasound (EUS)-Guided Liver Biopsy: A Comparison Between 19 Gauge Straight Standard (SSN) Versus Core Histology Needle (CHN) in Benign Hepatic Parenchymal Disease

Introduction: Liver biopsy (LB) is considered the gold standard in the diagnosis and staging of chronic liver disease. This is usually performed via the percutaneous or transvascular approach. Recent studies using 19G straight standard EUS FNA needles (SSN) have been shown to be safe and feasible with variable histological yields. A newly designed Core Histology Needle (CHN) has shown improved histological yield for malignant lesions sampled at EUS FNA. The utility of CHN in EUS guided LB, however, has not been compared to SSN. Methods: Patients from a single tertiary referral center underwent EUS-guided LB by experienced endosonographers using both the 19g SSN and/or CHN (both Cook Medical, Winston-Salem, NC). The “dynamic suction” technique with saline/heparin priming was used for both needles. Up to 20 to and fro motions of the needle was performed for each pass (up to 2), with Doppler “no-flow” confirmation prior to needle withdrawal. Key outcome measures were histological adequacy and complication rates. Histological adequacy was defined subjectively by theh ability to perform diagnosis or staging, and objectively by presence of ≥ 6 complete portal tracts (CPT). APERIO Imagescope system was used for specimen analysis. Complications were captured via post-procedural interview of all patients in person or by telephone. Student T test was used to calculate P value. Results: 30 patients underwent EUS-guided LB with either a 19g SSN or CHN. 2 patients had LB performed with both needles. Baseline patient characteristic were no different between both groups. 13 (43%) patients were suspected cirrhotics, 15 (50%) thrombocytopenic and 3 (10%) uremic on hemodialysis. Histology: Overall, subjectively, histology was deemed adequate in 25/32 (78%) by an expert liver pathologist. Objectively, histological yield was significantly greater in the SSN group vs CHN group (13/16 (81%) vs 7/16 (44%) p=0.014) (Table 1). Mean number of CPT was also significantly higher in SSN group vs CHN group (12.4 vs 6.9 p=0.015) (Table 2). The histological yield was reasonable in a difficult cohort of patients to biopsy, with 30% having a fibrosis stage (METAVIR) of 3 or greater.Table 1: Histological adequacy: Subjective and objectiveTable 2: Complete portal tracts (CPT), Partial portal tracts (PPT) and specimen lengthComplications: There were no major complications. 1 patient was admitted overnight for abdominal pain. Conclusion: EUS guided LB using 19G SSN outperforms CHN. The combination of a reasonable histologic adequacy and increasing safety data may support this novel method as an option for patients needing a liver biopsy.

Endoscopic Alcohol Ablation of Solid Tumors: Presidential Poster

FigureIntroduction: Recently there has been increasing interest in developing an endoscopic approach for the management and ablation of abdominal lesions, with some reports of success in the management of selected pancreatic cysts, neuroendocrine tumors, and abdominal metastases of other solid tumors. Methods: We describe a series six patients who underwent endoscopic alcohol ablation of a variety of solid tumors including a peripheral nerve sheath tumor, neuroendocrine tumor, metastatic foci from esophageal and rectal adenocarcinoma, and a functioning insulinoma Using both a direct endoscopic (EGD) and endoultrasonograpic (EUS) approach, successful ablation was performed with either ethanol or a 70:30 mixture of ethanol:bupivacaine, injected with either a 23 gauge variceal injection needle or 22 gauge EUS FNA needle. Results: Clinical improvement was appreciated in five of six cases, as measured by follow-up imaging, including EUS and PET/CT, and by resolution of symptoms, including obstructive symptoms and hypoglycemic episodes associated with insulinoma. The procedure was generally well tolerated; complications included duodenal ulcer and delayed pancreatitis. Conclusion: Endoscopic alcohol ablation circumvents the depth and location constraints imposed by conventional percutaneous methods, and allows minimally invasive treatment of solid lesions for patients in whom surgery is not feasible. This series demonstrates the safety and feasibility of endoscopic alcohol ablation of solid lesions and suggests that further research should be considered to determine the wider applicability of this technique in patients who have failed other conventional medical therapy or are not candidates for surgical resection.

Endoscopic Ultrasound-Guided, Needle-based Confocal Laser Endomicroscopy in the Diagnosis of Cystic Pancreatic Neuroendocrine Tumor: Emerging Imaging Criteria From Surgical Pathologic Correlation in Two Cases

Introduction: Cystic pancreatic neuroendocrine tumors (NETs) are relatively rare, with the reported incidence of < 10% of resected pancreatic cystic lesions. Preoperative diagnosis of cystic pancreatic NET remains challenging. Needle-based confocal laser endomicroscopy (nCLE) during EUS guided fine needle aspiration (EUS-FNA) has been shown to be useful in other pancreatic cystic neoplasms (ex Intraductal papillary mucinous neoplasia or IPMN). However, the utility of EUS-guided nCLE in the diagnosis of cystic pancreatic NET has not been reported, and imaging criteria based on surgical pathologic correlation has not been established. Methods: Under EUS guidance, the pancreatic cystic lesion was punctured with a 19-gauge FNA needle. After confirmation of cyst entry, fluorescein was injected intravenously. The nCLE probe was then advanced through the needle into the cyst, and the cyst wall was carefully imaged. Results: [Case 1] A 65 year-old-male presented for rapid enlargement over one year of a known pancreatic cystic neoplasm. On EUS, a 23X22 mm unilocular cystic lesion was seen in the pancreatic tail. There was no evidence of wall thickening or mural nodules. nCLE demonstrated a high density of dark thick cord-like structures or dark nest-like structures (Fig 1 ). There was no evidence of papillary projections, dark rings, or a superficial vasculature network, suggesting IPMN or serous cystadenoma, respectively. Laparoscopic distal pancreatectomy was performed. Histology of the resected specimen revealed well-differentiated pancreatic NET. nCLE images corresponded well to histological images (Fig 2).Figure 1Figure 2[Case2] A 71-year-old male with diabetes presented for evaluation of a pancreatic tail lesion seen on CT during investigation of abdominal pain. EUS demonstrated a 21X16 mm unilocular cystic lesion in the pancreatic tail with partial wall thickening. On nCLE, a high density of dark cord-like structures was observed. Distal pancreatectomy was performed and histology revealed a pancreatic NET. Conclusion: EUS-guided nCLE images correlated well with surgical pathology in 2 cases of cystic pancreatic NET. A high density of dark thick cord-like structures or dark nest-like structures may be important diagnostic criteria. If these criteria are prospectively validated, nCLE may play a role in the diagnosis of cystic pancreatic neuroendocrine tumors.