Background Unresectable malignant distal biliary obstruction (MDBO) may be treated with endoscopic ultrasound-guided (EUS-BD) or percutaneous transhepatic (PTBD) biliary drainage if endoscopic retrograde cholangiopancreatography fails or is not feasible. This study compared EUS-BD and PTBD using an improved ultrasound-guided method with primary metal stenting. Methods A prospective, longitudinal (follow-up 6 months), nonrandomized, noninferiority (10% margin) trial was conducted. Patients were assigned to centers with high competence in one of the two techniques. The primary end point was technical success, with propensity score matching employed to balance differences. Differences in secondary end points were evaluated with two-sided superiority analyses. Results 209 patients (mean age 73 years) were enrolled between December 2018 and August 2024 from 14 European centers and were subsequently matched 1:1. Noninferiority of PTBD vs. EUS-BD could not be demonstrated with regard to technical success (91.2% vs. 97.1%; P = 0.17; 95%CI -2.3% to 15.1%). Clinical success (intention-to-treat: 73.5% vs. 55.9%; P = 0.05), procedure time, length of hospital stay, and rate of biliary reintervention within 30 days (0.03 vs. 0.31; P < 0.001) were significantly better in the EUS-BD cohort, driven mainly by EUS-guided choledochoduodenostomy (EUS-CDS). No significant differences were observed in adverse events (grades 1-4) (16.7% vs. 14.5%; P = 0.82), pain score, clinical success (per-protocol), rate of biliary reinterventions within 6 months, or overall survival. Conclusions EUS-BD, particularly EU-CDS, might be preferred over PTBD in unresectable MDBO owing to better clinical success and a lower biliary reintervention rate.
To evaluate the effect of intraoperative administration of 1 g of tranexamic acid (TXA) on perioperative and postoperative outcomes in patients receiving antithrombotic therapy undergoing endoscopic enucleation of the prostate (EEP). This multicenter, prospective, observational study included 932 patients across 30 centers (December 2024–June 2025). Patients were divided into four groups based on TXA use and continuation or discontinuation of blood thinners during EEP. The primary endpoint was bleeding complications within 30 days, defined as a composite of transfusion, clot retention, bleeding requiring restart of continuous bladder washout (CBWO), or surgical reintervention to control hemostasis. Multivariable Logistic regression analysis identified independent predictors of bleeding complications. There were 534 patients in Group 1 (stopped blood thinners, no TXA given), 316 in Group 2 (on blood thinners, no TXA given), 69 in Group 3 (stopped blood thinners, TXA given), and 13 in Group 4 (on blood thinners, TXA given). Median total operative time was longest in Group 2 (88 min [IQR 70–127]) and shortest in Group 3 (55 min [IQR 39–69]). Hemostasis time was shortest in TXA groups (p < 0.001). Transfusions occurred in 0.6–7.7
INTRODUCTION:Endoscopic lung volume reduction with coils is a symptomatic treatment approach for patients with severe pulmonary emphysema and positive collateral ventilation. In this study, we evaluated the safety and feasibility of the new Lung Volume Reduction Reverser (LVR-R) system. METHODS:Prospective, nonrandomized, exploratory, single-center, first-in-man study in 15 patients with chronic obstructive pulmonary disease (COPD) and severe emphysema. Most affected lung lobes were treated sequentially with the LVR-R coils from May 2019 to JUL 2022. Pulmonary function, 6-min walking distance (6-MWD), questionnaires and adverse events were recorded from baseline to 1-year post-procedure. Computer tomography was acquired at baseline and 6 months. RESULTS:A total of 28 procedures were performed, in which 10 (n = 22, 78.6%), 9 (n = 2, 7.1%), or 8 (n = 4, 14.3%) LVR-R coils were implanted, predominantly in the upper lobes (n = 26/28, 92.86%). Two patients refused a second treatment, one of whom refused follow-ups. Adverse events at 3 months included severe pneumonia and/or COPD exacerbations (n = 7), ventilatory failure (n = 2) and 1 pneumothorax requiring thoracic drainage. Mild hemoptysis occurred in 18 and mild pneumonia and/or COPD exacerbations in 9 patients. Overall, neither FEV1, residual volume, 6-MWD, CAT nor mMRC improved within 1-year (n.s. all). In 2 patients, response in FEV1 >500 mL occurred. CONCLUSION:In this severely diseased and small patient cohort, LVR-R implantation was technically feasible. The complication rate was similar to other coil studies and requires a careful pre-procedure benefit-risk evaluation. Two of fourteen bilaterally treated individuals demonstrated a notable improvement in lung function.
