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Background The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes. Methods This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety. Results 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % [95 %CI 84.8 %–93.9 %] vs. 87.8 % [95 %CI 82.1 %–92.2 %]; P = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %–96.3 %] vs. 95.5 % [95 %CI 91.4 %–98 %]; P = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; P = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; P Conclusions The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.

Background and study aims Endoscopic ultrasound-guided through-the-needle biopsy (TTNB) of pancreatic cystic lesions (PCLs) is associated with a non-negligible risk for adverse events (AEs). We aimed to identify the hierarchic interaction among independent predictors for TTNB-related AEs and to generate a prognostic model using recursive partitioning analysis (RPA). Patients and methods Multicenter retrospective analysis of 506 patients with PCLs who underwent TTNB. RPA of predictors for AEs was performed and the model was validated by means of bootstrap resampling. Results Mean cysts size was 36.7 mm. Most common diagnoses were intraductal papillary mucinous neoplasm (IPMN, 45 %), serous cystadenoma (18.8 %), and mucinous cystadenoma (12.8 %). Fifty-eight (11.5 %) AEs were observed. At multivariate analysis, age (odds ratio [OR] 1.32, 1.09–2.14; p = 0.05), number of TTNB passes (OR from 2.17, 1.32–4.34 to OR 3.16, 2.03–6.34 with the increase of the number of passes), complete aspiration of the cyst (OR 0.56, 0.31–0.95; p = 0.02), and diagnosis of IPMN (OR 4.16, 2.27–7.69; p Conclusion TTNB should be selectively used in the evaluation of patients with IPMN. The present model could be applied during patient selection as to optimize the benefit/risk of TTNB.

Main Recommendations1 ESGE recommends the use of endoscopic ultrasound-guided biliary drainage (EUS-BD) over percutaneous transhepatic biliary drainage (PTBD) after failed endoscopic retrograde cholangiopancreatography (ERCP) in malignant distal biliary obstruction when local expertise is available.Strong recommendation, moderate quality evidence.2 ESGE suggests EUS-BD with hepaticogastrostomy only for malignant inoperable hilar biliary obstruction with a dilated left hepatic duct when inadequately drained by ERCP and/or PTBD in high volume expert centers.Weak recommendation, moderate quality evidence.3 ESGE recommends that EUS-guided pancreatic duct (PD) drainage should only be considered in symptomatic patients with an obstructed PD when retrograde endoscopic intervention fails or is not possible.Strong recommendation, low quality evidence.4 ESGE recommends rendezvous EUS techniques over transmural PD drainage in patients with favorable anatomy owing to its lower rate of adverse events.Strong recommendation, low quality evidence.5 ESGE recommends that, in patients at high surgical risk, EUS-guided gallbladder drainage (GBD) should be favored over percutaneous gallbladder drainage where both techniques are available, owing to the lower rates of adverse events and need for re-interventions in EUS-GBD.Strong recommendation, high quality of evidence.6 ESGE recommends EUS-guided gastroenterostomy (EUS-GE), in an expert setting, for malignant gastric outlet obstruction, as an alternative to enteral stenting or surgery.Strong recommendation, low quality evidence.7 ESGE recommends that EUS-GE may be considered in the management of afferent loop syndrome, especially in the setting of malignancy or in poor surgical candidates.Strong recommendation, low quality evidence.8 ESGE suggests that endoscopic ultrasound-directed transgastric ERCP (EDGE) can be offered, in expert centers, to patients with a Roux-en-Y gastric bypass following multidisciplinary decision-making, with the aim of overcoming the invasiveness of laparoscopy-assisted ERCP and the limitations of enteroscopy-assisted ERCP.Weak recommendation, low quality evidence.

Background A validated classification of endoscopic ultrasound (EUS) morphological characteristics and consequent therapeutic intervention(s) in pancreatic and peripancreatic fluid collections (PFCs) is lacking. We performed an interobserver agreement study among expert endosonographers assessing EUS-related PFC features and the therapeutic approaches used. Methods 50 EUS videos of PFCs were independently reviewed by 12 experts and evaluated for PFC type, percentage solid component, presence of infection, recognition of and communication with the main pancreatic duct (MPD), stent choice for drainage, and direct endoscopic necrosectomy (DEN) performance and timing. The Gwet’s AC1 coefficient was used to assess interobserver agreement. Results A moderate agreement was found for lesion type (AC1, 0.59), presence of infection (AC1, 0.41), and need for DEN (AC1, 0.50), while fair or poor agreements were stated for percentage solid component (AC1, 0.15) and MPD recognition (AC1, 0.31). Substantial agreement was rated for ability to assess PFC–MPD communication (AC1, 0.69), decision between placing a plastic versus lumen-apposing metal stent (AC1, 0.62), and timing of DEN (AC1, 0.75). Conclusions Interobserver agreement between expert endosonographers regarding morphological features of PFCs appeared suboptimal, while decisions on therapeutic approaches seemed more homogeneous. Studies to achieve standardization of the diagnostic endosonographic criteria and therapeutic approaches to PFCs are warranted.

Background Instead of choosing one endoscopic ultrasound (EUS) needle over the other, some advocate the use of fine-needle aspiration (FNA) and fine-needle biopsy (FNB) consecutively. We explored the yield of combined use of 20 G FNB and 25 G FNA needles in patients with a suspicious solid gastrointestinal lesion. Methods Patients from the ASPRO study who were sampled with both needles during the same procedure were included. The incremental yield of dual sampling compared with the yield of single needle use on the diagnostic accuracy for malignancy was assessed for both dual sampling approaches – FNA followed by FNB, and vice versa. Results 73 patients were included. There were 39 (53 %) pancreatic lesions, 18 (25 %) submucosal masses, and 16 (22 %) lymph nodes. FNA was used first in 24 patients (33 %) and FNB was used first in 49 (67 %). Generally, FNB was performed after FNA to collect tissue for ancillary testing (75 %), whereas FNA was used after FNB to allow for on-site pathological assessment (76 %). Diagnostic accuracy for malignancy of single needle use increased from 78 % to 92 % with dual sampling (P = 0.002). FNA followed by FNB improved the diagnostic accuracy for malignancy (P = 0.03), whereas FNB followed by FNA did not (P = 0.13). Conclusion Dual sampling only improved diagnostic accuracy when 25 G FNA was followed by 20 G FNB and not vice versa. As the diagnostic benefit of the 20 G FNB over the 25 G FNA needle has recently been proven, sampling with the FNB needle seems a logical first choice.

Main Recommendations1 ESGE recommends against diagnostic/therapeutic papillectomy when adenoma is not proven.Strong recommendation, low quality evidence.2 ESGE recommends endoscopic ultrasound and abdominal magnetic resonance cholangiopancreatography (MRCP) for staging of ampullary tumors.Strong recommendation, low quality evidence.3 ESGE recommends endoscopic papillectomy in patients with ampullary adenoma without intraductal extension, because of good results regarding outcome (technical and clinical success, morbidity, and recurrence).Strong recommendation, moderate quality evidence.4 ESGE recommends en bloc resection of ampullary adenomas up to 20–30 mm in diameter to achieve R0 resection, for optimizing the complete resection rate, providing optimal histopathology, and reduction of the recurrence rate after endoscopic papillectomy.Strong recommendation, low quality evidence.5 ESGE suggests considering surgical treatment of ampullary adenomas when endoscopic resection is not feasible for technical reasons (e. g. diverticulum, size > 4 cm), and in the case of intraductal involvement (of > 20 mm). Surveillance thereafter is still mandatory.Weak recommendation, low quality evidence.6 ESGE recommends direct snare resection without submucosal injection for endoscopic papillectomy.Strong recommendation, moderate quality evidence.7 ESGE recommends prophylactic pancreatic duct stenting to reduce the risk of pancreatitis after endoscopic papillectomy.Strong recommendation, moderate quality evidence.8 ESGE recommends long-term monitoring of patients after endoscopic papillectomy or surgical ampullectomy, based on duodenoscopy with biopsies of the scar and of any abnormal area, within the first 3 months, at 6 and 12 months, and thereafter yearly for at least 5 years.Strong recommendation, low quality evidence.

We report a 60-year-old woman with a previous history of an endoscopically treated walled-off necrosis that developed 12 months after an 80-mm recurrent symptomatic pancreatic body pseudocyst. Drainage was attempted using a 16 × 20-mm biflanged metal stent (Nagi), but the stent was mistakenly released inside the collection. A rescue attempt was made to retrieve the stent and avoid surgical intervention.

Background A forward-viewing linear (FVL) echoendoscope has been developed with the aim of overcoming some of the limitations of standard curved linear-array (CLA) echoendoscopes. There are no existing studies comparing the performance of the two echoendoscopes for endoscopic ultrasound-guided tissue acquisition (EUS-TA) of solid lesions other than subepithelial lesions. Methods This was a prospective, multicenter, randomized trial with a noninferiority design comparing FVL vs. CLA echoendoscopes in patients with solid lesions of the gastrointestinal tract or adjacent organs. Primary outcomes were successful identification of the lesion and success of EUS-TA. Secondary outcomes were safety, sensitivity, specificity, and diagnostic accuracy of the two different scopes for EUS-TA. Results 126 patients with solid lesions were randomly assigned to the CLA group (63 patients) or the FVL group (63 patients). The two groups were homogeneous with no differences in terms of needle type used, mean number of passes, and site of EUS-TA. No differences were observed between the FVL vs. CLA scopes in identification of the lesion (96.8 % vs. 98.4 %; P > 0.99) and technical success of EUS-TA (92.1 % vs. 96.8 %; P = 0.44). No adverse events occurred. Overall, diagnostic accuracy (77.8 % vs. 84.1 %), sensitivity (76.6 % vs. 84.1 %), and specificity (81.3 % vs. 84.2 %) did not differ between the two groups. Conclusions Our results strongly suggest that the FVL echoendoscope is noninferior to the CLA scope for the detection and performance of EUS-TA in patients with solid lesions of the gastrointestinal tract and adjacent organs. In addition, the FVL scope has the same diagnostic yield, accuracy, and safety as the CLA scope.

Background Management of biliary adverse events (BAEs) after biliodigestive anastomosis is challenging. We propose a new endoscopic approach to improve BAEs in this clinical setting. Methods Patients who had BAEs after a hepaticojejunostomy with Roux-en-Y loop or a Whipple procedure underwent creation of an entero-enteral endoscopic bypass (EEEB) between the duodenal/gastric wall and the biliary jejunal loop under endoscopic ultrasound (EUS) and fluoroscopic guidance using specifically designed fully covered self-expandable metal stents. Results 32 consecutive patients underwent EEEB, which was successful in all but one patient. One procedural and five long-term mild adverse events occurred. Endoscopic retrograde cholangiography (ERC) through the EEEB successfully treated all types of BAEs in these patients. Disease recurred in two patients who were successfully re-treated through the EEEB. Conclusions Our retrospective study showed that in patients with BAEs after biliodigestive anastomosis, EEEB is safe, feasible, and allows a successful long-term treatment of different BAEs in a tertiary referral center with high-level experience in both endoscopic retrograde cholangiopancreatography and EUS.

Background and study aims In patients with Barrett's esophagus (BE), targeted endoscopic mucosal resection (EMR) of visible lesions of high grade dysplasia (HGD) or intramucosal adenocarcinoma (IMC) is effective, but carries the risk of leaving in place synchronous lesions and Barrett's epithelium with the potential for recurrent disease. We evaluated the safety and long-term efficacy of complete Barrett's eradication EMR (CBE-EMR) for the treatment of patients with HGD or IMC, independently of the presence of macroscopically visible lesions or surgical risk. Patients and methods 26 consecutive patients with BE and HGD or IMC underwent CBE-EMRs, which were performed with the endoscopic cap suction method and/or a 2.3-mm monofilament mucosectomy snare. Endoscopic follow up after completion of resection was carried out to assess the rate of residual or recurrent BE with or without HGD or IMC. Results 24 patients completed the study. They underwent a total of 44 EMR sessions with a median of 3 pieces (range 1-8) removed per session. Two patients with immediate bleeding were successfully managed endoscopically. Three patients developed an early esophageal stricture that was completely resolved with a single endoscopic dilation. After a median follow-up of 28 months (range 15-51 months), persistent endoscopic and histologic eradication of BE was demonstrated in 21 patients (87.5 %). In two patients, Barrett's epithelium was detected beneath the neosquamous epithelium 3 months after completion of the resection. In the remaining patient, IMC was found in a nodule seen and removed by EMR at 12-month surveillance endoscopy. Conclusions CBE-EMR is a safe and highly effective long-term treatment that should be offered to all patients with Barrett's esophagus with HGD and IMC.

Endoscopic ultrasound (EUS)-guided fineneedle aspiration (FNA) is a safe procedure with a low complication rate [1]. To the best of our knowledge, there has only been one previous report of inadvertent fracturing of an FNA needle, which occurred during an attempted EUS-guided rendezvous for an inaccessible main pancreatic duct [2]. We present the case of a 75-year-old woman with an unresectable pancreatic head mass, who was referred to us for EUS-FNA after biliary stent placement. The procedure was performed by an experienced endosonographer from the duodenal bulb using a 22-gauge needle. The needle was inserted into the periphery of the mass to avoid passing through the plastic stent, and the fanning technique was used. At the end of the first pass, an unusual hyperreflecting line was observed, corresponding to the needle tract (●" Fig.1), which suggested that the needle may have broken during the sampling procedure. This was confirmed when the needle was advanced outside the external sheath to collect the specimen. The extremity of the broken needle was further identified protruding from the mucosa of the upper duodenal bulb (●" Fig.2). After various attempts at retrieval, the needle was grasped from the terminal end using a snare and was removed completely, without any consequences to the patient. The needle segment measured 4 cm (●" Fig.3,●" Video 1). There was no obvious cause of this incident. However, it is possible that the plastic stent could have been a relevant factor in the breaking of the needle. This case highlights the importance of ensuring that the correct EUS-FNA procedure is followed. After confirmation of a needle fracture, endoscopic removal can be accomplished with caution using the proper endoscopic accessories, in order to avoid potential damage to both the patient and the echoendoscope.

This article is the second of a two-part publication that expresses the current view of the European Society of Gastrointestinal Endoscopy (ESGE) about endoscopic ultrasound (EUS)-guided sampling, including EUS-guided fine needle aspiration (EUS-FNA) and EUS-guided Trucut biopsy. The first part (the Clinical Guideline) focused on the results obtained with EUS-guided sampling, and the role of this technique in patient management, and made recommendations on circumstances that warrant its use. The current Technical Guideline discusses issues related to learning, techniques, and complications of EUS-guided sampling, and to processing of specimens. Technical issues related to maximizing the diagnostic yield (e.g., rapid on-site cytopathological evaluation, needle diameter, microcore isolation for histopathological examination, and adequate number of needle passes) are discussed and recommendations are made for various settings, including solid and cystic pancreatic lesions, submucosal tumors, and lymph nodes. The target readership for the Clinical Guideline mostly includes gastroenterologists, oncologists, internists, and surgeons while the Technical Guideline should be most useful to endoscopists who perform EUS-guided sampling. A two-page executive summary of evidence statements and recommendations is provided.

This article is part of a combined publication that expresses the current view of the European Society of Gastrointestinal Endoscopy (ESGE) about endoscopic ultrasound (EUS)-guided sampling in gastroenterology, including EUS-guided fine needle aspiration (EUS-FNA) and EUS-guided trucut biopsy (EUS-TCB), of submucosal tumors, diffuse esophageal/gastric wall thickening, pancreatic solid masses and cystic-appearing lesions, mediastinal lesions unrelated to lung or esophageal cancer, cancer of the esophagus, stomach, and rectum, lymph nodes of unknown origin, adrenal gland masses, and focal liver lesions. False-positive cytopathological results and needle tract seeding are also discussed. The present Clinical Guideline describes the results of EUS-guided sampling in the different clinical settings, considers the role of this technique in patient management, and makes recommendations on circumstances that warrant its use. A two-page executive summary of evidence statements and recommendations is provided. A separate Technical Guideline describes the general technique of EUS-guided sampling, particular techniques to maximize the diagnostic yield depending on the nature of the target lesion, and sample processing. The target readership for the Clinical Guideline mostly includes gastroenterologists, oncologists, internists, and surgeons while the Technical Guideline should be most useful to endoscopists who perform EUS-guided sampling.

BACKGROUND AND STUDY AIMS Endoscopic retrograde cholangiopancreatography (ERCP) is the diagnostic procedure of choice in patients with biliary strictures and no culprit mass lesion on abdominal imaging, but it is limited in its diagnostic accuracy. The aim of this prospective study was to determine the value of intraductal ultrasound (IDUS) in distinguishing between benign and malignant biliary strictures in this clinical setting. PATIENTS AND METHODS Sixty-one patients with painless jaundice and no mass lesion on abdominal computed tomography, who were found to have a biliary stricture at ERCP, underwent IDUS with a high-frequency (20-MHz) wire-guided probe. Histopathological confirmation or clinical follow-up was used to establish the final diagnosis. The diagnostic performances of IDUS, ERCP, and IDUS plus ERCP in the identification of malignant strictures were evaluated. RESULTS Forty-three patients had malignant strictures and 18 had benign strictures. ERCP produced 25 false-negative diagnoses, 22 of which were identified as malignant by IDUS. IDUS provided seven false-negative and three false-positive diagnoses. The proportion of patients with malignant strictures who tested positive with IDUS was 2.06 times that of ERCP (95 % CI, 1.37 - 3.10; 83.3 % vs. 40.5 %, P = 0.0004). When used in conjunction, IDUS increased the accuracy of ERCP from 58 % to 90 %. Patients with operable lesions on IDUS and no contraindication to surgery underwent resection; most patients with pancreatic parenchymal invasion on IDUS underwent EUS, which identified a pancreatic mass in more than 50 % of cases. Patients with negative IDUS and a low clinical suspicion for malignancy were treated endoscopically, while a more aggressive work-up was performed in all patients with high pretest probability, regardless of the IDUS results. CONCLUSIONS IDUS is a valuable adjunct to ERCP in the characterization of biliary strictures in patients who present with painless jaundice in the absence of a culprit mass on abdominal imaging.

Emergent endoscopic retrograde cholangiopancreatography cannot be performed at the bedside in critically ill patients in an intensive care unit because of the requirement for fluoroscopy. Moving such patients to a safe location where fluoroscopy is available can pose practical problems, and can lead to delayed intervention, which may adversely affect the outcome. We report the use of intraductal ultrasound to facilitate therapeutic biliary interventions in four critically ill patients in an intensive care unit. Cannulation was performed endoscopically at the bedside using a sphincterotome and a guide wire. Intraductal ultrasound, rather than fluoroscopy, was then used to confirm the location of the wire within the common bile duct prior to performing endoscopic sphincterotomy or stent placement. This technique was successful in all four patients.