Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial).

BACKGROUND & AIMS: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). METHODS: In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. RESULTS: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. CONCLUSIONS: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. CLINICALTRIALS: gov, Number: NCT03870386.

Onsite evaluation of endoscopic ultrasound fine needle aspiration: the endosonographer, the cytotechnologist and the cytopathologist.

Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) has become an essential tool in the management of multiple diseases. Its accuracy is related to different aspects of the technique, one of the most important being the experience and interaction of the endosonographer and pathologist. Certain studies over the past years have highlighted the importance of having rapid on-site evaluation (ROSE) of samples obtained at the time of EUS-FNA. We have reviewed the role of ROSE, performed by the same endosonographer, a cytotechnologist and an expert cytopathologist. The available data suggest that ROSE (either by the endosonographer, the cytotechnologist, or the cytopathologist) improves sample adequacy and diagnostic yield, with the best option to have ROSE performed by an expert cytopathologist. However, if non-ROSE accuracy is already very high, any improvement is harder to achieve.

Differential diagnosis of small solid pancreatic lesions.

BACKGROUND AND AIMS: Pancreatic ductal adenocarcinoma (PDAC) is typically diagnosed at a late stage. Little is known about the incidental finding of early-stage PDAC. The aim of the current study was to determine the etiology of small solid pancreatic lesions (≤15 mm) to optimize clinical management. METHODS: Inclusion criterion for the retrospective study analysis was the incidental finding of primarily undetermined small solid pancreatic lesions ≤15 mm in 394 asymptomatic patients. Final diagnoses were based on histology or cytology obtained by imaging-guided biopsy (and at least 12-month follow-up) and/or surgery. Contrast-enhanced US or contrast-enhanced EUS was performed in 219 patients. RESULTS: The final diagnoses of 394 patients were as follows: 146 PDACs, 156 neuroendocrine tumors, 28 metastases into the pancreas from other primary sites, and 64 various other etiologies. Contrast-enhanced US allowed differential diagnosis of PDAC and non-PDAC in 189 of 219 patients (86%). CONCLUSIONS: Approximately 40% of patients with small solid pancreatic lesions had very early stage PDAC. Approximately 60% of small solid pancreatic lesions ≤15 mm are not PDAC and, therefore, do not require radical surgery. Without preoperative diagnosis, an unacceptably large proportion of patients would be exposed to radical surgery with significant morbidity and mortality.

EUS Needle Identification Comparison and Evaluation study (with videos).

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Randomized controlled trial comparing stylet-free endoscopic ultrasound-guided fine-needle aspiration with 22-G and 25-G needles.

BACKGROUND AND AIM: Previous studies comparing endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) results with different gauge needles have all been carried out with the stylet in place and show no clear advantage to the larger 22-G needle. Similar data for stylet-free EUS-FNA (SF-EUS-FNA) are unavailable. The aim of the present study was to determine whether diagnostic yield and specimen adequacy is superior with the 22-G needle as compared to the 25-G needle. METHODS: All patients ≥ 18 years referred for solid-lesion EUS-FNA were eligible. Patients with suspected diagnosis of lymphoma, gastrointestinal stromal tumor, sarcoidosis, significant coagulopathy (international normalized ratio > 1.5 or platelets < 50000/mm(3)), use of clopidogrel within 7 days of EUS, and pregnancy were excluded. The two needles were compared regarding diagnostic yield, sample adequacy, bloodiness, ease of puncture, visibility, number of passes, failures, and complications. RESULTS: One hundred and twenty consecutive patients were included and 126 lesions were sampled. Sensitivity, specificity, positive predictive value and negative predictive value for the 22-G SF-EUS-FNA were 83%, 100%, 100% and 56%, respectively, and for the 25-G SF-EUS-FNA were 88.8%, 100%, 100% and 76.5%, respectively (P=NS). There were no significant differences between the 22-G and the 25-G FNA needles in sample adequacy, bloodiness, ease of puncture, FNA failure, visibility, number of passes and complications; and no significant differences between either needle were found in relation to lesion site. CONCLUSION: For SF-EUS-FNA, the larger 22-G needle offers no advantage over the smaller 25-G needle.

Safety and efficacy of early versus late removal of LAMS for pancreatic fluid collections.

Background and study aims Optimal timing for removal of lumen-apposing metal stents (LAMS) for effective drainage of pancreatic fluid collections (PFC) while minimizing adverse events (AE) is unknown. Outcomes of early (≤ 4 weeks) or delayed (> 4 weeks) LAMS removal on both clinical efficacy and the incidence of AE were assessed. Patients and methods This was a retrospective analysis of a prospectively maintained registry of PFC drainage between November 2016 and September 2021. Clinical success was defined as a 75% decrease in fluid collection volume with no need for reintervention at 6 months. AE were defined using the American Society for Gastrointestinal Endoscopy lexicon. Multiple logistic regression analysis was performed to determine variables associated with clinical success and AE. Results A total of 108 consecutive PFCs were included. LAMS deployment was technically successful in 103 of 108 cases (95.4%). Failure was associated with collection diameter ≤ 4 cm (odds ratio [OR] 24.0, P = 0.005) and presence of more than 50% necrotic material (OR 20.1, P = 0.01). Stents were left in place for a median of 48 days. Patients with early stent removal (< 4 weeks) had clinical success in 70.0% of cases, which was significantly less than in the group with delayed stent removal (96.4%, P = 0.03). On multiple regression analysis, clinical failure was associated with early stent removal (OR 25.5, P = 0.003). AEs occurred in 8.7% of cases (9/103). There were no predictors of AE. Notably, delayed stent removal did not predict the occurrence of AE. Conclusions Early LAMS removal (< 4 weeks) did not prevent AEs but did lead to increased clinical failure.

Endohepatology: The endoscopic armamentarium in the hand of the hepatologist.

ABSTRACT: Recent advances in the field of hepatology include new and effective treatments for viral hepatitis. Further effort is now being directed to other disease entities, such as non-alcoholic fatty liver disease, with an increased need for assessment of liver function and histology. In fact, with the evolving nomenclature of fat-associated liver disease and the emergence of the term "metabolic-associated fatty liver disease" (MAFLD), new diagnostic challenges have emerged as patients with histologic absence of steatosis can still be classified under the umbrella of MAFLD. Currently, there is a growing number of endoscopic procedures that are pertinent to patients with liver disease. Indeed, interventional radiologists mostly perform interventional procedures such as percutaneous and intravascular procedures, whereas endoscopists focus on screening for and treatment of esophageal and gastric varices. EUS has proven to be of value in many areas within the realm of hepatology, including liver biopsy, assessment of liver fibrosis, measurement of portal pressure, managing variceal bleeding, and EUS-guided paracentesis. In this review article, we will address the endoscopic applications that are used to manage patients with chronic liver disease.

Comparison of endoscopic ultrasonography-guided fine-needle aspiration cytology results with and without the stylet in 3364 cases.

BACKGROUND AND AIM: Endoscopic ultrasound-guided fine-needle aspiration cytology (EUS-FNA) is traditionally carried out with the stylet, as it is believed to prevent blockage or contamination of the needle by tissue coming from the gastrointestinal wall. However, this recommendation has not been demonstrated on an empirical basis. The aim of the present study was to compare the yield of EUS-FNA in a very large series of patients with (S+) and without (S-) the stylet. METHODS: Until 2004, the stylet was used for EUS-FNA in our center. After that, the stylet was never used. The results of all EUS-FNA in solid lesions carried out by one endosonographer with the same needle type were compared before and after stylet use was stopped. RESULTS: 3364 EUS-FNA procedures (in 3078 patients) in solid lesions were included (1483 S+ and 1881 S-). There was no significant difference between the S+ and S- results for any variable other than the number of passes required. The number of passes was significantly lower in the S- group when sampling lymph nodes, wall lesions and when carrying out biopsies through the gastric or rectal wall. However the statistical differences disappeared after controlling for malignancy, location and lesion size. CONCLUSION: This very large comparative study showed no benefit in diagnostic yield when using the stylet for EUS-FNA.

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine.

BACKGROUND: Pancreatic cancer is a devastating disease with less than 5% 5-year survival. Inoperable patients often present with pain. Randomized controlled trial have shown that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) improves pain control. It is usually performed by injecting bupivacaine followed by absolute alcohol around the celiac axis. STUDY DESIGN: Single center, randomized, double blind controlled trial of EUS-CPN with and without bupivacaine in patients with inoperable malignancy (pancreatic or other) involving the celiac plexus. The study was approved by research ethics board with approval number of 2022-9969, 21.151 and registered on ClinicalTrials.gov (NCT04951804). DISCUSSION: We hypothesize that bupivacaine is superfluous and may actually reduce pain control by diluting the neurolytic effect of alcohol. Bupivacaine is also potentially dangerous in that it may produce serious adverse events such as arrythmias and cardiac arrest if inadvertently injected intravascularly. CONCLUSION: This randomized trial is designed to assess whether bupivacaine is of any value during EUS-CPN.

EUS-guided biliary drainage in malignant distal biliary obstruction: An international survey to identify barriers of technology implementation.

Background and Objectives: EUS-guided biliary drainage (EUS-BD) is a promising alternative to ERCP in malignant distal biliary obstruction (MDBO). Despite accumulating data, however, its application in clinical practice has been impeded by undefined barriers. This study aims to evaluate the practice of EUS-BD and its barriers. Methods: An online survey was generated using Google Forms. Six gastroenterology/endoscopy associations were contacted between July 2019 and November 2019. Survey questions measured participant characteristics, EUS-BD in different clinical scenarios, and potential barriers. The primary outcome was the uptake of EUS-BD as a first-line modality, without previous ERCP attempts, in patients with MDBO. Results: Overall, 115 respondents completed the survey (2.9% response rate). Respondents were from North America (39.2%), Asia (28.6%), Europe (20%), and other jurisdictions (12.2%). Regarding the uptake of EUS-BD as first-line treatment for MDBO, only 10.5% of respondents would consider EUS-BD as a first-line modality regularly. The main concerns were the lack of high-quality data, fear of adverse events, and limited access to EUS-BD dedicated devices. On multivariable analysis, lack of access to EUS-BD expertise was an independent predictor against the use of EUS-BD, odds ratio 0.16 (95% confidence interval, 0.04-0.65). In salvage situations following failed ERCP, most favored EUS-BD (40.9%) over percutaneous drainage (21.7%) in unresectable cancer. In borderline resectable or locally advanced disease, however, most favored the percutaneous approach due to fear of EUS-BD complicating future surgery. Conclusions: EUS-BD has not reached widespread clinical adoption. Identified barriers include lack of high-quality data, fear of adverse events, and lack of access to EUS-BD dedicated devices. Fear of complicating future surgery was also identified as a barrier in potentially resectable disease.

Safety and clinical efficacy of EUS-guided pelvic abscess drainage.

Background and Objectives: EUS is a potential alternative for the drainage of abscesses. The aim of this study was to determine if EUS-guided pelvic abscess drainage is technically feasible, safe, and a valid option for abscess resolution. Methods: We conducted a retrospective review from 2002 to 2020 at a single quaternary institution. EUS-guided pelvic abscess drainage via the transrectal route was performed in all patients with or without drain/stent placement. Technical and clinical success of EUS-guided pelvic abscess drainage was analyzed. Descriptive analyses and Fisher exact test were performed. Results: Sixty consecutive patients were included in the study (53.5% male; mean age, 53.8 ± 17.9 years). Pelvic abscesses occurred mainly postoperatively (33 cases; 60.0%) and from complicated diverticulitis (14 cases; 23.3%). Mean diameter was 6.5 ± 2.4 cm (80% unilocular). Drainage was performed with EUS-guided stent placement (double-pigtail plastic or lumen-apposing metal) in 74.5% of cases and with aspiration alone for the remainder. Technical success occurred in 58 cases (97%). Of those with long-term follow-up after EUS-guided pelvic abscess drainage (n = 55; 91.7%), complete abscess resolution occurred in 72.7% of all cases. Recurrence occurred in 8 cases (14.5%) and persisted in 7 patients (12.5%), 7 of which were successfully retreated with EUS-guided pelvic abscess drainage. Accounting for these successful reinterventions, the overall rate of abscess resolution was 85.5%. Abscess resolution rate improved with drain placement (83%). Accounting for 7 repeat EUS-guided pelvic abscess drainages, overall abscess resolution improved. Two deaths occurred (3.4%) because of sepsis from failed source control in patients who had previously failed medical, radiological, and surgical treatment. Conclusions: EUS-guided pelvic abscess drainage is technically feasible, safe, and an effective alternative to radiological or open surgical drainage. It also offers favorable clinical outcomes in different clinical situations.

EUS-guided celiac plexus neurolysis for pancreas cancer - Finally established or still under review?

Patients with pancreas cancer must deal frequently with intractable and refractory pain. Endoscopic ultrasound guided-celiac plexus neurolysis (EUS-CPN) has been the most studied and used therapeutic technique aimed to destroy the pain fibres that allow the pancreas to communicate with the central nervous system. A neurolytic agent, most commonly ethanol, is optimally spread around the celiac axis in order to reduce pain and mitigate narcotic requirements. This can be performed early to prevent the spiral of pain and medication use, or more historically as salvage therapy. Different techniques to best administer the ethanol for effective EUS-CPN are still being debated. New EUS-guided injection techniques with radiofrequency, radioactive, and/or chemotherapeutic agents need more study.

Endoscopic Ultrasound Guided Fine Needle Aspiration versus Endoscopic Ultrasound Guided Fine Needle Biopsy for Pancreatic Cancer Diagnosis: A Systematic Review and Meta-Analysis.

INTRODUCTION: One of the most effective diagnostic tools for pancreatic cancer is endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or biopsy (EUS-FNB). Several randomized clinical trials have compared different EUS tissue sampling needles for the diagnosis of pancreatic cancer. OBJECTIVE: To compare the diagnostic accuracy of EUS-guided FNA as EUS-FNB needles for the diagnosis of pancreatic cancer using a systematic review and meta-analysis. METHOD: A literature review with a meta-analysis was performed according to the PRISMA guide. The databases of PubMed, Cochrane and Google Scholar were used, including studies published between 2011-2021 comparing the diagnostic yield (diagnostic accuracy or probability of positivity, sensitivity, specificity, predictive value) of EUS-FNA and EUS-FNB for the diagnosis of pancreatic cancer. The primary outcome was diagnostic accuracy. Random effect models allowed estimation of the pooled odds ratio with a confidence interval (CI) of 95%. RESULTS: Nine randomized control trials were selected out of 5802 articles identified. Among these, five studies found no statistically significant difference between the EUS-FNA and EUS-FNB, whereas the other four did. The meta-analysis found EUS-FNB accuracy superior to EUS-FNA for the diagnosis of pancreatic cancer with a pooled odds ratio of 1.87 (IC 95%: 1.33-2.63). CONCLUSION: As compared to EUS-FNA, EUS-FNB seems to improve diagnostic accuracy when applied to suspicious pancreatic lesions.

Usefulness of endoscopic ultrasonography in hepatology.

Endoscopic ultrasonography (EUS) is used to evaluate patients with hepatobiliary diseases. The technique is useful for the diagnosis of esogastric varices in selected cases of portal hypertension, and to evaluate the pathogenic role and prognostic value of the collateral circulation in patients with this condition. When coupled with the Doppler technique, EUS can be used to guide injection sclerotherapy and to verify the obliteration of varices (particularly fundal varices) after endoscopic treatment. Hemodynamic changes induced in the collateral circulation by vasoactive drugs can also be measured with Doppler-EUS. Fine-needle aspiration under EUS guidance is useful in the diagnosis of focal liver lesions and perihepatic adenopathy, and in the evaluation of biliary tract diseases. New indications can be developed in the future after adequate experimental validation.

A randomized noninferiority trial comparing the diagnostic yield of the 25G ProCore needle to the standard 25G needle in suspicious pancreatic lesions.

BACKGROUND AND OBJECTIVES: The aim of the study was to perform the first randomized trial comparing the diagnostic yield, bloodiness, and cellularity of the 25G standard needle (25S) and the 25G ProCore™ needle (25P). MATERIALS AND METHODS: All patients referred to the tertiary care referral center for EUS guided fine-needle aspiration (EUS-FNA) of suspicious solid pancreatic lesions were eligible. EUS-FNA was performed in each lesion with both 25S and 25P needles (the choice of the first needle was randomized), using a multipass sampling pattern, without stylet or suction. Rapid on-site evaluation was used when possible. Pap-stained slides were read by a single experienced cytopathologist, blinded to the needle type. RESULTS: One hundred and forty-three patients were recruited. Samples were positive for cancer in 122/143 (85.3%) with the 25S needle versus 126/143 (88.1%) with the 25P needle, negative in 17/143 (11.9%) with the 25S needle versus 13/143 (9.1%) with the 25P needle, and suspicious in 4/143 (2.8%) with each needle. There was no difference in any outcome based on the type of the first needle. No carryover effect was detected (P = 0.214; NS). Cumulative logistic regression analyses showed no associations between the type of needle and diagnostic yield for cancer, cellularity, or bloodiness. The difference in the yield for cancer was 2.9% (-4.2; 10.1%); with the confidence interval upper within the predetermined noninferiority margin of 15%. CONCLUSION: The 25S needle is noninferior to the 25P needle for diagnosing cancer in suspicious pancreatic lesions.

Controversies in EUS: Do we need miniprobes?

This is the fifth in a series of papers entitled "Controversies in EUS." In the current paper, we deal with high-resolution catheter probes, otherwise known as EUS miniprobes (EUS-MPs). The application of miniprobes for early carcinomas in the entire intestinal tract, for subepithelial lesions, and for findings in the bile duct and pancreatic duct as well as endobronchial use is critically discussed. Submucous lesions, especially in the colon, but also early carcinomas in special cases are considered the most important indications. The argument is illustrated by numerous examples.