Pure Cut or Endocut for Biliary Sphincterotomy? A Multicenter Randomized Clinical Trial.

INTRODUCTION: Adverse events (AE) after endoscopic retrograde cholangiopancreatography (ERCP) are not uncommon and post-ERCP acute pancreatitis (PEP) is the most important one. Thermal injury from biliary sphincterotomy may play an important role and trigger PEP or bleeding. Therefore, this study evaluated the outcomes of 2 electric current modes used during biliary sphincterotomy. METHODS: From October 2019 to August 2021, consecutive patients with native papilla undergoing ERCP with biliary sphincterotomy were randomized to either the pure cut or endocut after cannulation. The primary outcome was PEP incidence. Secondary outcomes included intraprocedural and delayed bleeding, infection, and perforation. RESULTS: A total of 550 patients were randomized (272 pure cut and 278 endocut). The overall PEP rate was 4.0% and significantly higher in the endocut group (5.8% vs 2.2%, P = 0.034). Univariate analysis revealed >5 attempts ( P = 0.004) and endocut mode ( P = 0.034) as risk factors for PEP. Multivariate analysis revealed >5 attempts ( P = 0.005) and a trend for endocut mode as risk factors for PEP ( P = 0.052). Intraprocedural bleeding occurred more often with pure cut ( P = 0.018), but all cases were controlled endoscopically during the ERCP. Delayed bleeding was more frequent with endocut ( P = 0.047). There was no difference in perforation ( P = 1.0) or infection ( P = 0.4999) between the groups. DISCUSSION: Endocut mode may increase thermal injury leading to higher rates of PEP and delayed bleeding, whereas pure cut is associated with increased intraprocedural bleeding without clinical repercussion. The electric current mode is not related to perforation or infection. Further RCT assessing the impact of electric current on AE with overlapping preventive measures such as rectal nonsteroidal anti-inflammatory drugs and hyperhydration are needed. The study was submitted to the Brazilian Clinical Trials Platform ( http://www.ensaiosclinicos.gov.br ) under the registry number RBR-5d27tn.

Self-Expandable Metal Stent (SEMS) Versus Lumen-Apposing Metal Stent (LAMS) for Drainage of Pancreatic Fluid Collections: A Randomized Clinical Trial.

Background and aim Endoscopic ultrasound (EUS)-guided drainage is the gold standard approach for the treatment of encapsulated pancreatic collections (EPCs) including pseudocyst and walled-off pancreatic necrosis (WON), and is associated with an equivalent clinical efficacy to surgical drainage with fewer complications and less morbidity. Drainage may be achieved via several types of stents including a fully covered self-expandable metallic stent (SEMS) and lumen-apposing metal stent (LAMS). However, to date there have been no randomized trials to compare these devices. This study aimed to compare the efficacy and safety of the SEMS versus LAMS for EUS-guided drainage of EPCs. Methods A phase IIB randomized trial was designed to compare the SEMS versus LAMS for the treatment of EPCs. Technical success, clinical success, adverse events (AEs), and procedure time were evaluated. A sample size of 42 patients was determined. Results There was no difference between the two groups in technical (LAMS 80.95% vs 100% SEMS, p=0.107), clinical (LAMS 85.71% vs 95.24% SEMS, p=0.606) or radiological success (LAMS 92.86% vs 83.33% SEMS, p=0.613). There was no difference in AEs including stent migration rate and mortality. The procedure time was longer in the LAMS group (mean time 43.81 min versus 24.43 min, p=0.001). There was also a difference in the number of intra-procedure complications (5 LAMS vs 0 SEMS, p=0.048). Conclusion SEMS and LAMS have similar technical, clinical, and radiological success as well as AEs. However, SEMS has a shorter procedure time and fewer intra-procedure complications compared to non-electrocautery-enhanced LAMS in this phase IIB randomized controlled trial (RCT). The choice of the type of stent used for EUS drainage of EPCs should consider device availability, costs, and personal and local experience.

Managing adverse events after endoscopic ultrasound-guided drainage of the biliary tract and pancreatic fluid collections: Narrative review (with video).

Endoscopic ultrasound (EUS)-guided therapeutic procedures have become increasingly common in clinical practice. The development of EUS-guided fine needle aspiration cytology led to the concept of interventional EUS. However, it carries a considerable risk of adverse events (AEs), which occur in approximately 23% of the procedures performed for the drainage of pancreatic fluid collections and 2.5-37.0% of those performed for drainage of the biliary tract. Although the vast majority of AEs occurring after EUS-guided drainage are mild, a deep understanding of such events is necessary for their appropriate management. Because EUS-guided drainage is a novel procedure, there have been few studies of the topic. To our knowledge, this is the first narrative review that focuses on the management and resolution of AEs occurring after EUS-guided drainage of pancreatic fluid collections or the biliary tract. We also include an explanatory video.

Colonoscopic Ultrasound-Guided Fine-Needle Aspiration Using a Curvilinear Array Transducer: A Single-Center Retrospective Cohort Study.

BACKGROUND: Curvilinear array ultrasound transducers enable tissue sampling and have therapeutic capabilities. Nevertheless, colonic intubation and maneuvering with these transducers is technically challenging and is therefore typically limited to the rectosigmoid area. This retrospective cohort study aimed to evaluate the safety, feasibility, and diagnostic yield of colonoscopic ultrasound-guided fine-needle aspiration in deep colonic intubation. IMPACT OF INNOVATION: The impact of this innovation is to enable tissue sampling of colonic and extracolonic lesions guided by endoscopic ultrasound. TECHNOLOGY, MATERIALS, AND METHODS: Curvilinear array ultrasound is used in the evaluation of luminal and extraluminal colonic diseases. Thirteen patients underwent colonoscopic ultrasound with a curvilinear array ultrasound endoscope in a single center for subepithelial lesions, cancer staging, and extracolonic lesions from July 2015 to February 2021. Endosonography was performed using an Olympus EU-ME1 and GF-UCT 180 with a 5-12MHz curvilinear array transducer. The primary outcome was the percentage of patients who were successfully scanned with the endoscopic ultrasound. The secondary outcomes included the success rate of fine-needle aspiration, the diagnostic yield of the tissue samples, and the adverse events related to the procedure. PRELIMINARY RESULTS: A total of 13 female patients underwent colonoscopic ultrasound. All patients (100%, 13/13) were successfully scanned. Fine-needle aspiration was deemed necessary and successfully performed in 100% (5/5) of the patients. Tissue samples collected by fine-needle aspiration resulted in a diagnostic yield of 60%, and no adverse events resulted from this intervention. CONCLUSIONS: This study demonstrates the feasibility of performing colonoscopic ultrasound with a curvilinear array transducer. Fine-needle aspiration for subepithelial, colonic, and extracolonic lesions is feasible and safe in this setting with no adverse events reported in our study. FUTURE DIRECTIONS: Future research should be directed toward validating colonoscopic ultrasound with a curvilinear array transducer technique in prospective randomized trials. Studies evaluating the feasibility and safety of endoscopic ultrasound-guided interventions in the colon, such as abscess drainage and enteral anastomosis, should be considered.

Association between mucosal surface pattern under near focus technology and Helicobacter pylori infection.

BACKGROUND: Many studies evaluated magnification endoscopy (ME) to correlate changes on the gastric mucosal surface with Helicobacter pylori (H. pylori) infection. However, few studies validated these concepts with high-definition endoscopy without ME. AIM: To access the association between mucosal surface pattern under near focus technology and H. pylori infection status in a western population. METHODS: Cross-sectional study including all patients referred to routine upper endoscopy. Endoscopic exams were performed using standard high definition (S-HD) followed by near focus (NF-HD) examination. Presence of erythema, erosion, atrophy, and nodularity were recorded during S-HD, and surface mucosal pattern was classified using NF-HD in the gastric body. Biopsies were taken for rapid urease test and histology. RESULTS: One hundred and eighty-seven patients were analyzed from August to November 2019. Of those, 47 (25.1%) were H. pylori+, and 42 (22.5%) had a previous H. pylori treatment. In the examination with S-HD, erythema had the best sensitivity for H. pylori detection (80.9%). Exudate (99.3%), nodularity (97.1%), and atrophy (95.7%) demonstrated better specificity values, but with low sensitivity (6.4%-19.1%). On the other hand, the absence of erythema was strongly associated with H. pylori- (negative predictive value = 92%). With NF-HD, 56.2% of patients presented type 1 pattern (regular arrangement of collecting venules, RAC), and only 5.7% of RAC+ patients were H. pylori+. The loss of RAC presented 87.2% sensitivity for H. pylori detection, 70.7% specificity, 50% positive predictive value, and 94.3% negative predictive value, indicating that loss of RAC was suboptimal to confirm H. pylori infection, but when RAC was seen, H. pylori infection was unlikely. CONCLUSION: The presence of RAC at the NF-HD exam and the absence of erythema at S-HD were highly predictive of H. pylori negative status. On the other hand, the loss of RAC had a suboptimal correlation with the presence of H. pylori.

Pancreatitis after endoscopic retrograde cholangiopancreatography: A narrative review.

Acute post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is a feared and potentially fatal complication that can be as high as up to 30% in high-risk patients. Pre-examination measures, during the examination and after the examination are the key to technical and clinical success with a decrease in adverse events. Several studies have debated on the subject, however, numerous topics remain controversial, such as the effectiveness of prophylactic medications and the amylase dosage time. This review was designed to provide an update on the current scientific evidence regarding PEP available in the literature.

Endoscopic Band Ligation Versus Argon Plasma Coagulation in the Treatment of Gastric Antral Vascular Ectasia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND/AIMS: Argon plasma coagulation (APC) is the most commonly used endoscopic treatment for gastric antral vascular ectasia (GAVE). Endoscopic band ligation (EBL) has emerged as an alternative therapy. Our goal was to evaluate the feasibility, efficacy, and safety of APC and EBL for the treatment of GAVE. This is the first systematic review that included only randomized controlled trials (RCTs) on this topic. METHODS: A comprehensive search was performed using electronic databases to identify RCTs comparing APC and EBL for the treatment of GAVE following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. RESULTS: Four RCTs were included, with a total of 204 patients. EBL was related to higher endoscopic eradication rates risk difference [RD], 0.29; 95% confidence interval [CI] [0.14, 0.44]; I2=0%) and less bleeding recurrence than APC (RD, 0.29; 95% CI [0.15, 0.44]; I2=0%). Patients treated with EBL required fewer blood transfusions (mean difference [MD], 1.49; 95% CI [0.28, 2.71]; I2=96%) and hospitalizations (MD, 0.29; 95% CI [0.19, 0.39]; I2=0%). The number of sessions required for the obliteration of lesions was higher with APC. There was no difference in the incidence of adverse events. CONCLUSION: EBL is superior to APC in the treatment of GAVE in terms of endoscopic eradication rates, recurrence of bleeding, and transfusion requirements.

Adverse Events and Complications with Intragastric Balloons: a Narrative Review (with Video).

Intragastric balloon (IGB) is a minimally invasive and reversible therapy for weight loss with a good efficacy and safety profile. Introduced in the 1980s, IGBs have significantly evolved in the last couple of decades. They mechanically act by decreasing the volume of the stomach and its reservoir capacity, delaying gastric emptying, and increasing satiety leading to a subsequent weight loss. Despite the low rates of complications and mortality associated with IGBs, adverse events and complications still occur and can range from mild to fatal. This review aims to provide an update on the current scientific evidence in regard to complications and adverse effects of the use of the IGB and its treatment. This is the first comprehensive narrative review in the literature dedicated to this subject.

Role of pancreatography in the endoscopic management of encapsulated pancreatic collections - review and new proposed classification.

Pancreatic fluids collections are local complications related to acute or chronic pancreatitis and may require intervention when symptomatic and/or complicated. Within the last decade, endoscopic management of these collections via endoscopic ultrasound-guided transmural drainage has become the gold standard treatment for encapsulated pancreatic collections with high clinical success and lower morbidity compared to traditional surgery and percutaneous drainage. Proper understanding of anatomic landmarks, including assessment of the main pancreatic duct and any associated lesions - such as disruptions and strictures - are key to achieving clinical success, reducing the need for reintervention or recurrence, especially in cases with suspected disconnected pancreatic duct syndrome. Additionally, proper review of imaging and anatomic landmarks, including collection location, are pivotal to determine type and size of pancreatic stenting as well as approach using long-term transmural indwelling plastic stents. Pancreatography to adequately assess the main pancreatic duct may be performed by two methods: Either non-invasively using magnetic resonance cholangiopancreatography or endoscopically via retrograde cholangiopan-creatography. Despite the critical need to understand anatomy via pancrea-tography and assess the main pancreatic duct, a standardized approach or uniform assessment strategy has not been described in the literature. Therefore, the aim of this review was to clarify the role of pancreatography in the endoscopic management of encapsulated pancreatic collections and to propose a new classification system to aid in proper assessment and endoscopic treatment.

Suction versus slow-pull for endoscopic ultrasound-guided fine-needle aspiration of pancreatic tumors: a prospective randomized trial.

BACKGROUND: Suction (S) is commonly used to improve cell acquisition during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). Slow-pull (SP) sampling is another technique that might procure good quality specimens with less bloodiness. We aimed to determine if SP improves the diagnostic yield of EUS-FNA of pancreatic masses. METHODS: Patients with pancreatic solid masses were randomized to four needle passes with both techniques in an alternate fashion. Sensitivity, specificity, positive, and negative predictive values were calculated. Cellularity and bloodiness of cytological samples were assessed and compared according to the technique. RESULTS: Sensitivity, specificity, and accuracy of suction vs. SP were 95.2% vs. 92.3%; 100% vs. 100; 95.7% vs. 93%, respectively. As to the association of methods, they were 95.6, 100 and 96%, respectively. Positive predictive values for S and SP were 100%. There was no difference in diagnostic yield between S and SP (p = 0.344). Cellularity of samples obtained with SP and Suction were equivalent in both smear evaluation (p = 0.119) and cell-block (0.980). Bloodiness of SP and suction techniques were similar as well. CONCLUSIONS: S and SP techniques provide equivalent sensitivity, specificity, and accuracy. Association of methods seems to improve diagnostic yield. Suction does not increase the bloodiness of samples compared to slow-pull.

Endoscopic ultrasound-guided vs endoscopic retrograde cholangiopancreatography biliary drainage for obstructed distal malignant biliary strictures: A systematic review and meta-analysis.

BACKGROUND: For palliation of malignant biliary obstruction (MBO), the gold-standard method of biliary drainage is endoscopic retrograde cholangiopancreatography (ERCP) with the placement of metallic stents. Endoscopic ultrasound (EUS)-guided drainage is an alternative that is typically reserved for cases of ERCP failure. Recently, however, there have been robust randomized clinical trials (RCTs) comparing EUS-guided drainage and ERCP as primary approaches to MBO. AIM: To compare EUS guidance and ERCP in terms of their effectiveness and safety in palliative biliary drainage for MBO. METHODS: This was a systematic review and meta-analysis, in which we searched the MEDLINE, Excerpta Medica, and Cochrane Central Register of Controlled Trials databases. Only RCTs comparing EUS and ERCP for primary drainage of MBO were eligible. All of the studies selected provided data regarding the rates of technical and clinical success, as well as the duration of the procedure, adverse events, and stent patency. We assessed the risk of biases using the Jadad score and the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation criteria. RESULTS: The database searches yielded 5920 records, from which we selected 3 RCTs involving a total of 222 patients (112 submitted to EUS and 110 submitted to ERCP). In the EUS and ERCP groups, the rate of technical success was 91.96% and 91.81%, respectively, with a risk difference (RD) of 0.00% (95%CI: -0.07, 0.07; P = 0.97; I 2 = 0%). The clinical success was 84.81% and 85.53% in the EUS and ERCP groups, respectively, with an RD of -0.01% (95%CI: -0.12, 0.10; P = 0.90; I 2 = 0%). The mean difference (MD) for the duration of the procedure was -0.12% (95%CI: -8.20, 7.97; P = 0.98; I 2 = 84%). In the EUS and ERCP groups, there were 14 and 25 adverse events, respectively, with an RD of -0.06% (95%CI: -0.23, 0.12; P = 0.54; I 2 = 77%). The MD for stent patency was 9.32% (95%CI: -4.53, 23.18; P = 0.19; I 2 = 44%). The stent dysfunction rate was significantly lower in the EUS group (MD = -0.22%; 95CI:-0.35, -0.08; P = 0.001; I 2 = 0%). CONCLUSION: EUS represents an interesting alternative to ERCP for MBO drainage, demonstrating lower stent dysfunction rates compared with ERCP. Technical and clinical success, duration, adverse events and patency rates were similar.

Endoscopic versus surgical treatment for pancreatic pseudocysts: Systematic review and meta-analysis.

OBJECTIVE: This systematic review and meta-analysis aims to compare surgical and endoscopic treatment for pancreatic pseudocyst (PP). METHODS: The researchers did a search in Medline, EMBASE, Scielo/Lilacs, and Cochrane electronic databases for studies comparing surgical and endoscopic drainage of PP s in adult patients. Then, the extracted data were used to perform a meta-analysis. The outcomes were therapeutic success, drainage-related adverse events, general adverse events, recurrence rate, cost, and time of hospitalization. RESULTS: There was no significant difference between treatment success rate (risk difference [RD] -0.09; 95% confidence interval [CI] [0.20,0.01]; P = .07), drainage-related adverse events (RD -0.02; 95% CI [-0.04,0.08]; P = .48), general adverse events (RD -0.05; 95% CI [-0.12, 0.02]; P = .13) and recurrence (RD: 0.02; 95% CI [-0.04,0.07]; P = .58) between surgical and endoscopic treatment.Regarding time of hospitalization, the endoscopic group had better results (RD: -4.23; 95% CI [-5.18, -3.29]; P < .00001). When it comes to treatment cost, the endoscopic arm also had better outcomes (RD: -4.68; 95% CI [-5.43,-3.94]; P < .00001). CONCLUSION: There is no significant difference between surgical and endoscopic treatment success rates, adverse events and recurrence for PP. However, time of hospitalization and treatment costs were lower in the endoscopic group.

EUS-Guided Intragastric Injection of Botulinum Toxin A in the Preoperative Treatment of Super-Obese Patients: a Randomized Clinical Trial.

BACKGROUND: Obesity is a disease that is highly prevalent in Brazil, and the associated comorbidities represent a major global public health challenge. Botulinum toxin type A (BTX-A) is a potent neurotoxin and inhibitor of gastric smooth muscle activity. In theory, BTX-A administration should promote early satiety and weight loss because it delays gastric emptying by inhibiting acetylcholine-mediated peristalsis, which is primarily responsible for gastric motility. Because results in the literature are discrepant, the efficacy of intragastric injections of BTX-A as a primary treatment for obesity remains unknown. The objective of this prospective, double-blind, single-center randomized study was to evaluate the effects of endoscopic ultrasound-guided intragastric BTX-A injections, as a bridge to bariatric surgery, in super-obese patients. METHODS: Thirty-two super-obese patients were randomized to one of two groups: BTX-A, in which 200 units of BTX-A were injected into the gastric antrum and body; and control, in which the same injections were performed with 0.9% saline. Weight, body mass index (BMI), and loss of excess weight were measured monthly over a 6-month period. Gastric emptying scintigraphy was performed before and after the procedure. RESULTS: The patients in both groups showed significant weight loss over the course of the study (p < 0.001). There were no statistically significant differences between the groups regarding weight loss, excess weight, total loss of excess weight, total weight loss, or change in BMI. CONCLUSIONS: Intragastric injection of BTX-A does not appear to be an effective method of achieving preoperative weight loss in super-obese patients.