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Abstract Background It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction. Methods/design This is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate). Discussion The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction. Trial registration ClinicalTrials.gov NCT04595058 . Registered on October 14, 2020.

Background and study aims Traditionally in the case of a vascular interposition, endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has been contraindicated. A transvascular route (TV) is feasible and probably a safe alternative approach in selected patients, but data are scarce. The primary aim of this study was to analyze the diagnostic yield and safety of EUS-TV-FNA in thoracic and abdominal lesions. Secondary aims included evaluation of the clinical impact and technical aspects. Patients and methods A retrospective multicenter study was conducted with inclusion of all consecutive patients that underwent EUS-TV-FNA from July 2007 to January 2020. Feasibility, cytopathology, procedure details, and safety were evaluated. Univariate analysis was performed to identify variables associated with incidents, cytopathological diagnosis, and clinical impact. Results Data were collected from a total of 49 cases and 50 EUS-TV-FNAs. The aorta (n = 19) and portal system (n = 17) were the most frequently punctured. The most frequent lesions were mediastinal lymph nodes (n = 13) and pancreatic tumors (n = 11). The diagnostic yield was 86 %, and there were nondiagnostic samples in seven cases. Overall sensitivity, specificity, and accuracy were 88 % (95 %CI,0.74–0.96), 100 % (95 %CI,0.59–1), and 90 % (95 %CI,0.78–0.96), respectively. Only three incidents were detected: two mural hematomas and a self-limited bleeding of gastroduodenal artery. In most patients, there was a significant impact on clinical management (88 %). Arterial vessel and ASA-III had a trend with incidents (both, P

BackgroundEndoscopic ultrasound-guided biliary drainage (EUS-BD) was associated with better clinical success and a lower rate of adverse events (AEs) than fluoroscopy-guided percutaneous transhepatic biliary drainage (PTBD) in recent single center studies with mainly retrospective design and small case numbers (< 50). The aim of this prospective European multicenter study is to compare both drainage procedures using ultrasound-guidance and primary metal stent implantation in patients with malignant distal bile duct obstruction (PUMa Trial).MethodsThe study is designed as a non-randomized, controlled, parallel group, non-inferiority trial. Each of the 16 study centers performs the procedure with the best local expertise (PTBD or EUS-BD). In PTBD, bile duct access is performed by ultrasound guidance. EUS-BD is performed as an endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided antegrade stenting (EUS-AGS). Insertion of a metal stent is intended in both procedures in the first session. Primary end point is technical success. Secondary end points are clinical success, duration pf procedure, AEs graded by severity, length of hospital stay, re-intervention rate and survival within 6 months. The target case number is 212 patients (12 calculated dropouts included).DiscussionThis study might help to clarify whether PTBD is non-inferior to EUS-BD concerning technical success, and whether one of both interventions is superior in terms of efficacy and safety in one or more secondary endpoints. Randomization is not provided as both procedures are rarely used after failed endoscopic biliary drainage and study centers usually prefer one of both procedures that they can perform best.Trial registrationClinicalTrials.gov ID: NCT03546049 (22.05.2018).

Background and study aims Approximately 11 % of biliary cannulations are considered difficult. The double guidewire (DGW-T) and transpancreatic sphincterotomy (TPS) are two useful techniques when difficult cannulation exists and the main pancreatic duct is unintentionally accessed. We carried out a systematic review and meta-analysis to evaluate the effectiveness and security of both DGW-T and TPS techniques in difficult biliary cannulation. Methods We conducted a systematic review in different databases, such as PubMed, OVID, Medline, and Cochrane Databases. Were included all RCT which showed a comparison between TPS and DGW in difficult biliary cannulation. Endpoints computed were successful cannulation rate, median cannulation time, and adverse events rate. Results Four studies were selected (4 RCTs). These studies included 260 patients. The mean age was 64.79 ± 12.99 years. Of the patients, 53.6 % were men and 46.4 % were women. The rate of successful cannulation was 93.3 % in the TPS group and 79.4 % in the DGW-T group (P = 0.420). The rate of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) was lower in patients who had undergone TPS than DGW-T (TPS: 8.9 % vs DGW-T: 22.2 %, P = 0.02). The mean cannulation time was 14.7 ± 9.4 min in the TPS group and 15.1 ± 7.4 min with DGW-T (P = 0.349). Conclusions TPS and DGW are two useful techniques in patients with difficult cannulation. They both have a high rate of successful cannulation; however, the PEP was higher with DGW-T than with TPS.

Background and study aims Pancreatic cystic lesions (PCL), are a heterogeneous group of cystic lesions. Some patients with PCLs have a significantly higher overall risk of pancreatic cancer and the only test that can differentiate benign and malignnat PCL is fine-needle aspiration plus cytological analysis, but its sensitivity is very low. Through-the-needle direct intracystic biopsy is a technique that allows acquisition of targeted tissue from PCLs and it may improve the diagnostic yield for them. The aim of this study was to review articles about endoscopic ultrasound (EUS)-guided through-the-needle intracystic biopsy for targeted tissue acquisition and diagnosis of PCLs. Methods A systematic review of computerized bibliographic databases was carried out for studies of EUS-guided through-the-needle forceps biopsy (EUS-TTNB) of PCLs. The percentages and their 95 % confidence intervals (CIs) were calculated for all the considered endpoints (technical success, adequate specimens, adverse events (AEs), and overall diagnosis). Results Overall, eight studies with a total of 423 patients were identified. Pooled technical success was 95.6 % of the cases (399/423), (95 % CI, 93.2 %–97.3 %). Technical failure rate was 5.1 % (24 cases). Frequency of adequate specimens was 82.2 %, (95 % CI, 78.5 %–85.8 %). Adverse events were reported in seven of the eight studies. Forty-two total adverse events were reported (10.1 %) (95 % CI, 7.3 %–13.6 %). The overall ability to provide a specific diagnosis with EUS-TTNB for diagnosis of pancreatic cystic lesions was 74.6 % (313 cases), (95 % CI: 70.2 %–78.7 %). The most frequent diagnoses found with EUS-TTNB were mucinous cystic neoplasms (MCN) in 96 cases (30.6 %), IPMN in 80 cases (25.5 %), and serous cystoadenoma neoplasm (SCN) in 48 cases (15.3 %). Conclusions Through-the-needle forceps biopsy appears to be effective and safe, with few AE for diagnosis of pancreatic cystic lesions. This technique had acceptable rates of technical and clinical success and an excellent safety profile. TTNB is associated with a high tissue acquisition yield and provided additional diagnostic yield for mucinous pancreatic lesions. TTNB may be a useful adjunctive tool for EUS-guided assessment of PCLs.