RESUMO
BACKGROUND AND AIM: Delayed endoscopic sphincterotomy-related bleeding (ES bleeding) is an unavoidable adverse event (AE) that can have serious ramifications. Intraoperative ES bleeding, which stops spontaneously in most cases, is a known risk factor for delayed bleeding. This study aimed to examine the preventive effect of a novel self-assembling peptide (SAP) for delayed ES bleeding in patients who attained spontaneous hemostasis after intraoperative ES bleeding. METHODS: A total of 1507 patients met the eligibility criteria for inclusion in this study. The rates of delayed ES bleeding and AE besides bleeding were compared between patients administered the SAP (SAP group) and those who were simply observed after spontaneous hemostasis of intraoperative ES bleeding (control group). Propensity score matching was performed to adjust for differences between the groups. RESULTS: The rate of delayed ES bleeding was significantly lower in the SAP group than that in the control group (0.9% vs 3.8%, P = 0.044). The rates of AEs other than bleeding were 2.4% and 3.8% in the SAP and control groups, respectively, and the difference lacked statistical significance (P = 0.481). Multivariate analysis revealed that the use of SAP was significantly associated with a lower frequency of delayed ES bleeding (odds ratio, 0.35; 95% confidence interval, 0.13-0.98; P = 0.047). CONCLUSIONS: Self-assembling peptide may be a simple, safe, and useful way to reduce the risk of delayed ES bleeding in patients who experienced intraoperative ES bleeding and obtained subsequent spontaneous hemostasis.
RESUMO
BACKGROUND: Endoscopic trisectoral metal stent (MS) placement for malignant hilar biliary obstruction (MHBO) poses technical challenges, although it may prolong survival and stent patency. Combined stent-by-stent and stent-in-stent (SBSIS) methods can reduce technical difficulty. This study aimed to examine the use of the SBSIS in patients with Bismuth type III or IV MHBO. METHODS: This prospective pilot study enrolled 30 eligible patients between January 2020 and October 2022. The study outcomes included technical and clinical success, recurrent biliary obstruction (RBO), and adverse events (AE) besides RBO associated with SBSIS for MHBO. RESULTS: The technical success rate was 93.3% (28/30 patients). Clinical success was achieved in all patients with technical success. The early and late AEs rates were 6.7% (2/30) and 7.1% (2/28), respectively. The incidence of RBO was 35.7% (10/28). RBO was treated with an endoscopic transpapillary approach in eight patients and an endoscopic ultrasound-guided transmural approach in two patients. The median time to RBO was 162 days, and the median overall survival was 148 days. CONCLUSIONS: This first prospective study investigating the SBSIS method demonstrated good technical feasibility with a low AE rate. Therefore, it can be considered a better option when contemplating trisectoral MS placement for high-grade MHBO.