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.

Homemade endoscopic vacuum therapy device for the management of transmural gastrointestinal defects.

OBJECTIVES: Endoscopic vacuum therapy (EVT) possesses a unique mechanism of action providing a less invasive alternative for the management of transmural gastrointestinal defects (TGID). This study evaluates the efficacy and safety of a novel homemade EVT (H-EVT) for the treatment of TGID. METHODS: Retrospective multicenter study including patients who underwent H-EVT for TGID between January 2019 and January 2022. Main outcomes included technical and clinical success as well as safety outcomes. Subgroup analyses were included by defect location and classification. Logistic regression analyses were performed to determine predictors for successful closure. RESULTS: A total of 144 patients were included. Technical success was achieved in all patients, with clinical success achieved in 88.89% after a mean of 3.49 H-EVT exchanges over an average of 23.51 days. After excluding 10 cases wherein it was not possible to achieve negative pressure, successful closure occurred in 95.52% of patients. Time to clinical success was less for defects caused by endoscopic (hazard ratio [HR] 0.63; 95% confidence interval [CI] 0.33-1.20) compared to surgical procedures and for patients with simultaneous intracavitary and intraluminal H-EVT placement (HR 0.70; 95% CI 0.55-0.91). Location and classification of defect did not impact clinical success rate. Simultaneous placement of both an intraluminal and intracavitary H-EVT (odds ratio 3.08; 95% CI 1.19-7.95) was a significant predictor of clinical success. Three device-related adverse events (2.08%) occurred. CONCLUSIONS: The use of the H-EVT is feasible, safe, and effective for the management of TGID.

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.

Intraductal radiofrequency ablation plus biliary stent versus stent alone for malignant biliary obstruction: a systematic review and meta-analysis.

Background and study aims Recurrent biliary stent occlusion and tumor ingrowth remain a major concern among patients with malignant biliary obstruction (MBO) with significant impact on patient morbidity and survival. Intraductal radiofrequency ablation (RFA) has emerged as a promising treatment that seeks to extend stent patency. This study aimed to evaluate the impact of RFA on overall survival (OS) and stent patency among patients with unresectable MBO. Methods A comprehensive search of electronic databases was performed for randomized controlled trials (RCTs) comparing RFA plus biliary stent (RFA+S) versus biliary stent alone (S-alone). Outcomes assessed included overall survival, stent patency, and adverse events (AEs) with mean difference (MD) calculated from pooled proportions. Subgroup analyses were performed for hilar strictures and cholangiocarcinoma (CCA). Results Six RCTs (n=439 patients) were included and demonstrated improved survival among patients who received RFA+S (MD 85.80 days; 95% confidence interval [CI] 35.02-136.58; I 2 =97%; P <0.0009). The pooled MD for total stent patency was 22.25 days (95% CI 17.38-61.87; I 2 =97%; P =0.27). There was no difference in AEs between RFA+S vs S-alone ( P >0.05). On subgroup analyses, RFA+S was associated with improved stent patency (MD 76.73 days; 95% CI 50.11-103.34; I 2 =67%; P <0.01) and OS (MD 83.14 (95% CI 29.52-136.77; I 2 =97%; P <0.01] for CCA. For hilar strictures, stent patency was improved among patients with RFA+S [MD 83.71 days (95% CI 24.85-142.56; I 2 =84%; P <0.01]. Conclusions RFA+S improved OS in the treatment of MBO when compared with S-alone. Moreover, the RFA therapy prolonged stent patency in hilar strictures and CCA, with similar rates of AEs.

Correction: Intraductal radiofrequency ablation plus biliary stent versus stent alone for malignant biliary obstruction: a systematic review and meta-analysis.

[This corrects the article DOI: 10.1055/a-2204-8316.].

Complex Intrahepatic Lithiasis: A Case Report of Combined Treatment With Surgical Exploration of the Bilioenteric Anastomosis and Laser Lithotripsy by Cholangioscopy.

Intrahepatic lithiasis, or hepatolithiasis, is an endemic disease in southeast Asia, although, with immigration from Eastern countries, the incidence of this pathology is rising worldwide. The Latin American experience demonstrates morbidity and mortality compatible with other Western countries, but minimally invasive procedures are lacking. We demonstrate a case of a combined surgical and endoscopic approach for stone clearance. We present a case of a 47-year-old female patient with biliary enteric anastomosis to treat recurrent pyogenic cholangitis resulting from intrahepatic lithiasis. The patient was admitted to the emergency room, presented with a new episode of cholangitis, and submitted to transcutaneous hepatobiliary drainage. The multidisciplinary approach, including the endoscopic and surgical teams, successfully performed the stone clearance with laser lithotripsy and stone removal by open access. The postoperative period was uneventful, and the patient did not present any sign of recurrence after one year. A combined surgical and endoscopic approach achieved short-term clinical and technical success in this novel case. Moreover, individualizing cases requiring open surgical access is feasible, which allows a combined endoscopic approach with safety.

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.

Endoscopic Treatment of Complex Walled-Off Necrosis in Necrotizing Pancreatitis With Two Simultaneous Lumen-Apposing Metal Stents: A Case Report.

Organized pancreatic and peripancreatic collections are complications of pancreatitis and should be treated when symptomatic or complicated. When feasible, the endoscopic ultrasound approach presents high efficacy and low morbidity and mortality, making it the first likely option. Among the available accessories for endoscopic drainage, the lumen-apposing metal stent can be a better option, with a low migration rate; furthermore, it allows endoscopic necrosectomy. Here, we present the case of complex walled-off necrosis treated with two lumen-apposing metal stents in the same procedure. A 41-year-old male patient with walled-off necrosis presented with delayed gastric emptying and obstruction of the main biliary duct. Magnetic resonance imaging and endoscopic ultrasound revealed two non-communicating collections. We opted for endoscopic ultrasound-guided drainage with the deployment of two simultaneous lumen-apposing metal stents: one transduodenal and the other transgastric, with clinical improvement. After three weeks, endoscopic retrograde cholangiopancreatography showed a biliary fistula communicating with the periduodenal collection, which was treated with a biliary plastic stent. An endoscopic necrosectomy was performed, and the metal stents were removed. Control magnetic resonance imaging demonstrated improvement. The patient was asymptomatic at the six-month follow-up. The treatment of symptomatic complex walled-off necrosis remains a challenge and may require multiple endoscopic approaches; moreover, surgical treatment may be necessary in case of failure. In the present report, we demonstrate that the deployment of two lumen-apposing metal stents in the same procedure is feasible when necessary as it was associated with technical success and short-term clinical success.

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.

II Brazilian consensus statement on endoscopic ultrasonography.

BACKGROUND AND OBJECTIVES: At the time of its introduction in the early 80s, endoscopic ultrasonography (EUS) was indicated for diagnostic purposes. Recently, EUS has been employed to assist or to be the main platform of complex therapeutic interventions. METHODS: From a series of relevant new topics in the literature and based on the need to complement the I Brazilian consensus on EUS, twenty experienced endosonographers identified and reviewed the pertinent literature in databases. The quality of evidence, strength of recommendations, and level of consensus were graded and voted on. RESULTS: Consensus was reached for eight relevant topics: treatment of gastric varices, staging of nonsmall cell lung cancer, biliary drainage, tissue sampling of subepithelial lesions (SELs), treatment of pancreatic fluid collections, tissue sampling of pancreatic solid lesions, celiac neurolysis, and evaluation of the incidental pancreatic cysts. CONCLUSIONS: There is a high level of evidence for staging of nonsmall cell lung cancer; biopsy of SELs as the safest method; unilateral and bilateral injection techniques are equivalent for EUS-guided celiac neurolysis, and in patients with visible ganglia, celiac ganglia neurolysis appears to lead to better results. There is a moderate level of evidence for: yield of tissue sampling of pancreatic solid lesions is not influenced by the needle shape, gauge, or employed aspiration technique; EUS-guided and percutaneous biliary drainage present similar clinical success and adverse event rates; plastic and metallic stents are equivalent in the EUS-guided treatment of pancreatic pseudocyst. There is a low level of evidence in the routine use of EUS-guided treatment of gastric varices.

Deep sedation during gastrointestinal endoscopy: propofol-fentanyl and midazolam-fentanyl regimens.

AIM: To compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy. METHODS: After obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observer's assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ² test, measurement of analysis of variance, and the κ statistic. RESULTS: The times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination. CONCLUSION: Deep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.