Sammy Ho

Initial experience with a novel EUS-guided core biopsy needle (SharkCore): results of a large North American multicenter study.

Background and aims: The ability to safely and effectively obtain sufficient tissue for pathologic evaluation by using endoscopic ultrasound (EUS) guidance remains a challenge. Novel designs in EUS needles may provide for improved ability to obtain such core biopsies. The aim of this study was to evaluate the diagnostic yield of core biopsy specimens obtained using a novel EUS needle specifically designed to obtain core biopsies. Patients and methods: Multicenter retrospective review of all EUS-guided fine-needle biopsies obtained using a novel biopsy needle (SharkCore FNB needle, Medtronic, Dublin, Ireland). Data regarding patient demographics, lesion type/location, technical parameters, and diagnostic yield was obtained. Results: A total of 250 lesions were biopsied in 226 patients (Median age 66 years; 113 (50 %) male). Median size of all lesions (mm): 26 (2 – 150). Overall, a cytologic diagnosis was rendered in 81 % specimens with a median number of 3 passes. When rapid onsite cytologic evaluation (ROSE) was used, cytologic diagnostic yield was 126/149 (85 %) with a median number of 3 passes; without ROSE, cytologic diagnostic yield was 31/45 (69 %, P = 0.03) with a median number of 3 passes. Overall, a pathologic diagnosis was rendered in 130/147 (88 %) specimens with a median number of 2 passes. Pathologic diagnostic yield for specific lesion types: pancreas 70/81 (86 %), subepithelial lesion 13/15 (87 %), lymph node 26/28 (93 %). Ten patients (10/226, 4 %) experienced adverse events: 4 acute pancreatitis, 5 pain, 1 fever/cholangitis. Conclusions: Initial experience with a novel EUS core biopsy needle demonstrates excellent pathologic diagnostic yield with a minimum number of passes.

Pre- and post-training session evaluation for interobserver agreement and diagnostic accuracy of probe-based confocal laser endomicroscopy for biliary strictures

Current diagnostic modalities for indeterminate biliary strictures offer low accuracy. Probe‐based confocal laser endomicroscopy (pCLE) permits microscopic assessment of mucosal structures by obtaining real‐time high‐resolution images of the mucosal layers of the gastrointestinal tract. Previously, an interobserver study demonstrated poor to fair agreement even among experienced confocal endomicroscopy operators. Our objective was to assess interobserver agreement and diagnostic accuracy upon completion of a pCLE training session.

A multi-institutional consensus on how to perform endoscopic ultrasound-guided peri-pancreatic fluid collection drainage and endoscopic necrosectomy

There is a lack of consensus on how endoscopic ultrasound (EUS)-guided pseudocyst drainage and endoscopic necrosectomy should be performed. This survey was carried out amongst members of the EUS Journal Editorial Board to describe their practices in performing this procedure. This was a worldwide multi-institutional survey amongst members of the EUS Journal Editorial Board in May 2017. The responses to a 22-question survey with respect to the practice of EUS-guided pseudocyst drainage and endoscopic necrosectomy were obtained. Twenty-two endoscopists responded to the questionnaire as follows: 72.7% (16/22) were of the opinion that lumen-apposing metal stents (LAMS) should be the standard of care for the creation of an endoscopic cystenterostomy in patients with pancreatic walled-off necrosis (WON); 95.5% (21/22) recommended large diameter (d=15 mm) LAMS for drainage in patients with WON; 54.5% (12/22) would not dilate LAMS after placement into the WOPN; 86.4% (19/22) would not perform endoscopic necrosectomy during the same procedure as the creation of the cystenterostomy; 45.5% (10/22) recommend that agents, such as diluted hydrogen peroxide, should be used to lavage the peri-pancreatic fluid collection (PFC) cavity in patients with WON; and 45.5% (10/22) considered a naso-cystic or other tube to be necessary for lavage of WON after initial drainage. The mean optimal interval recommended for endoscopic necrosectomy procedures after EUS-guided drainage was 6.23 days. The mean optimal interval recommended for repeat imaging in patients undergoing endoscopic necrosectomy was 12.32 days. The mean time recommended for LAMS removal was 4.59 weeks. This is the first worldwide survey on the practice of EUS-guided pseudocyst drainage and endoscopic necrosectomy. There were wide variations in practice and randomized studies are urgently needed to establish the best approach for management of this condition. There is also a pressing need to establish a best practice consensus.

Practice patterns in FNA technique: A survey analysis.

AIM To ascertain fine needle aspiration (FNA) techniques by endosonographers with varying levels of experience and environments. METHODS A survey study was performed on United States based endosonographers. The subjects completed an anonymous online electronic survey. The main outcome measurements were differences in needle choice, FNA technique, and clinical decision making among endosonographers and how this relates to years in practice, volume of EUS-FNA procedures, and practice environment. RESULTS A total of 210 (30.8%) endosonographers completed the survey. Just over half (51.4%) identified themselves as academic/university-based practitioners. The vast majority of respondents (77.1%) identified themselves as high-volume endoscopic ultrasound (EUS) (> 150 EUS/year) and high-volume FNA (> 75 FNA/year) performers (73.3). If final cytology is non-diagnostic, high-volume EUS physicians were more likely than low volume physicians to repeat FNA with a core needle (60.5% vs 31.2%; P = 0.0004), and low volume physicians were more likely to refer patients for either surgical or percutaneous biopsy, (33.4% vs 4.9%, P < 0.0001). Academic physicians were more likely to repeat FNA with a core needle (66.7%) compared to community physicians (40.2%, P < 0.001). CONCLUSION There is significant variation in EUS-FNA practices among United States endosonographers. Differences appear to be related to EUS volume and practice environment.

Practice guidelines for endoscopic ultrasound-guided celiac plexus neurolysis

Objectives: The objective of guideline was to provide clear and relevant consensus statements to form a practical guideline for clinicians on the indications, optimal technique, safety and efficacy of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN). Methods: Six important clinical questions were determined regarding EUS-CPN. Following a detailed literature review, 6 statements were proposed attempting to answer those questions. A group of expert endosonographers convened in Chicago, United States (May 2016), where the statements were presented and feedback provided. Subsequently a consensus group of 35 expert endosonographers voted based on their individual level of agreement. A strong recommendation required 80% voter agreement. The modified GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria were used to rate the strength of recommendations and the quality of evidence. Results: Eighty percent agreement was reached on 5 of 6 consensus statements, 79.4% agreement was reached on the remaining one. Conclusions: EUS-CPN is efficacious, should be integrated into the management of pancreas cancer pain, and can be considered early at the time of diagnosis of inoperable disease. Techniques may still vary based on operator experience. Serious complications exist, but are rare.

Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones

BACKGROUND & AIMS: It is not clear whether digital single‐operator cholangioscopy (D‐SOC) with electrohydraulic and laser lithotripsy is effective in removal of difficult biliary stones. We investigated the safety and efficacy of D‐SOC with electrohydraulic and laser lithotripsy in an international, multicenter study of patients with difficult biliary stones. METHODS: We performed a retrospective analysis of 407 patients (60.4% female; mean age, 64.2 years) who underwent D‐SOC for difficult biliary stones at 22 tertiary centers in the United States, United Kingdom, or Korea from February 2015 through December 2016; 306 patients underwent electrohydraulic lithotripsy and 101 (24.8%) underwent laser lithotripsy. Univariate and multivariable analyses were performed to identify factors associated with technical failure and the need for more than 1 D‐SOC electrohydraulic or laser lithotripsy session to clear the bile duct. RESULTS: The mean procedure time was longer in the electrohydraulic lithotripsy group (73.9 minutes) than in the laser lithotripsy group (49.9 minutes; P < .001). Ducts were completely cleared (technical success) in 97.3% of patients (96.7% of patients with electrohydraulic lithotripsy vs 99% patients with laser lithotripsy; P = .31). Ducts were cleared in a single session in 77.4% of patients (74.5% by electrohydraulic lithotripsy and 86.1% by laser lithotripsy; P = .20). Electrohydraulic or laser lithotripsy failed in 11 patients (2.7%); 8 patients were treated by surgery. Adverse events occurred in 3.7% patients and the stone was incompletely removed from 6.6% of patients. On multivariable analysis, difficult anatomy or cannulation (duodenal diverticula or altered anatomy) correlated with technical failure (odds ratio, 5.18; 95% confidence interval, 1.26–21.2; P = .02). Procedure time increased odds of more than 1 session of D‐SOC electrohydraulic or laser lithotripsy (odds ratio, 1.02; 95% confidence interval, 1.01–1.03; P < .001). CONCLUSIONS: In a multicenter, international, retrospective analysis, we found D‐SOC with electrohydraulic or laser lithotripsy to be effective and safe in more than 95% of patients with difficult biliary stones. Fewer than 5% of patients require additional treatment with surgery and/or extracorporeal shockwave lithotripsy to clear the duct.

Comparing EUS-Fine Needle Aspiration and EUS-Fine Needle Biopsy for Solid Lesions: A Multicenter, Randomized Trial

BACKGROUND & AIMS Endoscopic ultrasound with fine‐needle aspiration (FNA) is the standard of care for tissue sampling of solid lesions adjacent to the gastrointestinal tract. Fine‐needle biopsy (FNB) may provide higher diagnostic yield with fewer needle passes. The aim of this study was to assess the difference in diagnostic yield between FNA and FNB. METHODS This is a multicenter, prospective randomized clinical trial from 6 large tertiary care centers. Patients referred for tissue sampling of solid lesions were randomized to either FNA or FNB of the target lesion. Demographics, size, location, number of needle passes, and final diagnosis were recorded. RESULTS After enrollment, 135 patients were randomized to FNA (49.3%), and 139 patients were randomized to FNB (50.7%).The following lesions were sampled: mass (n = 210, 76.6%), lymph nodes (n = 46, 16.8%), and submucosal tumors (n = 18, 6.6%). Final diagnosis was malignancy (n = 192, 70.1%), reactive lymphadenopathy (n = 30, 11.0%), and spindle cell tumors (n = 24, 8.8%). FNA had a diagnostic yield of 91.1% compared with 88.5% for FNB (P = .48). There was no difference between FNA and FNB when stratified by the presence of on‐site cytopathology or by type of lesion sampled. A median of 1 needle pass was needed to obtain a diagnostic sample for both needles. CONCLUSIONS FNA and FNB obtained a similar diagnostic yield with a comparable number of needle passes. On the basis of these results, there is no significant difference in the performance of FNA compared with FNB in the cytologic diagnosis of solid lesions adjacent to the gastrointestinal tract. ClinicalTrials.gov identifier: NCT01698190.

The Accuracy of Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) for Diagnosing Solid Pancreatic Lesions Using a New 25-Gauge Needle System

The Accuracy of Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) for Diagnosing Solid Pancreatic Lesions Using a New 25-Gauge Needle System Sammy Ho, Robert Bonasera, Hazar Michael, Bonnie Pollack, James Grendell, Mala Gupta, Martin Feuerman, Simcha Pollack, Frank Gress Introduction: EUS-FNA has enhanced our ability to diagnose pancreatic masses. Most of the published data is based on the use of a 22-gauge needle. The aim of this study was to evaluate our center’s experience with a new disposable 25-gauge needle system in the diagnosis of solid pancreatic lesions.Methods: Our institution began utilizing this FDA approved 25-gauge EUS-FNA needle system (Echotip, Wilson Cook, Winston Salem, NC) in 2/2001. All patients referred for EUS evaluation of solid pancreatic mass between 2/2001 and 12/2002 were reviewed. Patient demographics, clinical history including follow-up, and pathology findings were recorded. Cytopathology was compared with operative histopathology in patients who had surgery. Patients who did not have surgery were followed clinically. Results: A total of 163 patients (mean age 66, 88 M/75 F) underwent EUS-FNA for solid pancreatic lesions using the 25-gauge needle. FNA was consistent with pancreatic malignancy in 48% (78/163) while 45% (74/163) had no evidence of malignancy. In the remaining 7% (11/163), biopsy was inconclusive. No complications were reported. Of the pancreatic cancer patients, 96% (75/78) had adenocarcinoma and 4% (3/78) had other malignancies. In the group with a definitive FNA diagnosis, 14% (23/163) underwent surgery and operative histopathology was compared with FNA cytopathology. There was one falsenegative and no false-positive diagosis; and the sensitivity, specificity, PPV, and NPV were 94%, 100%, 100%, and 86% respectively. In the false-negative case, patient had cytologic evidence of chronic pancreatitis. In patients with an inconclusive FNA, 27% (3/11) had surgery and 2 had adenocarcinoma. The remaining 84% (137/163) of patients who did not undergo surgery were followed clinically. The mean survival for patients with a positive, negative, and inconclusive FNA was 11, 23, and 14 months respectively. Conclusions: 1. EUSFNA using a 25-gauge needle system can accurately and safely provide a cytologic diagnosis of pancreatic masses. 2. The patient who had a false-negative FNA diagnosis had chronic pancreatitis, confirming previous reports that cytologic evaluation of pancreatic tissue in the setting of chronic inflammation can be difficult. 3. Studies with larger sample size and randomized arms are now needed to further assess the accuracy and complication rate of this smaller needle system.

Endoscopic ultrasound-guided drainage of pelvic abscesses with lumen-apposing metal stents

The development of pelvic abscesses is a well‐described complication of abdominal and pelvic surgery and is associated with numerous medical conditions including diverticulitis, inflammatory bowel disease, ischemic colitis, and pelvic inflammatory disease.[1] Numerous therapeutic modalities have been described in the literature, including percutaneous, surgical, transrectal, transvaginal, and transgluteal drainage.[2-4] Complex pelvic anatomy and presence of loculations are often barriers to successful percutaneous drainage and historically required surgical management.

Comparison of Endoscopic Ultrasound–Fine-needle Aspiration and Endoscopic Ultrasound–Fine-needle Biopsy for Solid Lesions in a Multicenter, Randomized Trial

BACKGROUND & AIMS Endoscopic ultrasound with fine‐needle aspiration (FNA) is the standard of care for tissue sampling of solid lesions adjacent to the gastrointestinal tract. Fine‐needle biopsy (FNB) may provide higher diagnostic yield with fewer needle passes. The aim of this study was to assess the difference in diagnostic yield between FNA and FNB. METHODS This is a multicenter, prospective randomized clinical trial from 6 large tertiary care centers. Patients referred for tissue sampling of solid lesions were randomized to either FNA or FNB of the target lesion. Demographics, size, location, number of needle passes, and final diagnosis were recorded. RESULTS After enrollment, 135 patients were randomized to FNA (49.3%), and 139 patients were randomized to FNB (50.7%).The following lesions were sampled: mass (n = 210, 76.6%), lymph nodes (n = 46, 16.8%), and submucosal tumors (n = 18, 6.6%). Final diagnosis was malignancy (n = 192, 70.1%), reactive lymphadenopathy (n = 30, 11.0%), and spindle cell tumors (n = 24, 8.8%). FNA had a diagnostic yield of 91.1% compared with 88.5% for FNB (P = .48). There was no difference between FNA and FNB when stratified by the presence of on‐site cytopathology or by type of lesion sampled. A median of 1 needle pass was needed to obtain a diagnostic sample for both needles. CONCLUSIONS FNA and FNB obtained a similar diagnostic yield with a comparable number of needle passes. On the basis of these results, there is no significant difference in the performance of FNA compared with FNB in the cytologic diagnosis of solid lesions adjacent to the gastrointestinal tract. ClinicalTrials.gov identifier: NCT01698190.