This single-center comparative randomized superiority study compared biliary stenting using fully covered selfexpandable metal stents (FCSEMS) and biliary stenting using plastic stents (PS) in preoperative biliary drainage of patients with borderline resectable pancreatic cancer (BRPC) who are planned to undergo a single regimen of neo-adjuvant chemotherapy (NAC).Methods: Twenty-two patients with BRPC who required preoperative biliary drainage before NAC (Gemcitabine plus Nabpaclitaxel) were randomly assigned 1:1 to the FCSEMS or PS group. The primary endpoint was the rate of stent dysfunction until surgery or tumor progression. Secondary endpoints were stent patency, number of re-interventions, adverse events of endoscopic retrograde biliary drainage (EBD), operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs.Results: Eleven patients in each of the groups reached the primary endpoint. The FCSEMS group showed a significantly lower rate of stent dysfunction (18.2% vs. 72.8%, P = 0.015), longer stent patency (P = 0.02), and lower number of reinterventions for stent dysfunction (0.27 AE 0.65 vs. 1.27 AE 1.1, P = 0.001) than the PS group. The adverse events of EBD, operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs did not significantly differ between the two groups.Conclusions: In patients with BRPC for preoperative biliary drainage, stent dysfunction occurred less frequently with FCSEMSs than with PSs. In addition, FCSEMS and PS provided similar preoperative management of BRPC in terms of the safety of surgery and medical costs. (UMIN ID000030473).
Background/Aims: Rosemont classification (RC) with endoscopic ultrasonography (EUS) is important for diagnosing chronic pancreatitis (CP) but is based only on subjective judgement. EUS shear wave measurement (EUS-SWM) is a precise modality based on objective judgment, but its usefulness has not been extensively studied yet. This study evaluated the utility of EUS-SWM for diagnosing CP and estimating CP severity by determining the presence of endocrine dysfunction along with diabetes mellitus (DM). Methods: Between June 2018 and December 2018, 52 patients who underwent EUS and EUS-SWM were classified into two groups according to RC: non-CP (indeterminate CP and normal) and CP (consistent and suggestive of CP). The EUS-SWM value by shear wave velocity was evaluated with a median value. The EUS-SWM value was compared with RC and the number of EUS features. The diagnostic accuracy and cutoff value of EUS-SWM for CP and DM and its sensitivity and specificity were calculated. Results: The EUS-SWM value significantly positively correlated with the RC and the number of EUS features. The EUS-SWM values that were consistent and suggestive of CP were significantly higher than that of normal. The area under the receiver operating characteristic (AUROC) curve for the diagnostic accuracy of EUS-SWM for CP was 0.97. The cutoff value of 2.19 had 100% sensitivity and 94% specificity. For endocrine dysfunction in CP, the AUROC was 0.75. The cutoff value of 2.78 had 70% sensitivity and 56% specificity. Conclusions: EUS-SWM provides an objective assessment and can be an alternative diagnostic tool for diagnosing CP. EUS-SWM may also be useful for predicting the presence of endocrine dysfunction.
Background and Aim Recurrences after endoscopic treatment of common bile duct stones (CBDS) are common. The aims of this study were to identify risk factors for recurrences of CBDS and to evaluate the effect of interventions for prevention of further recurrences. Methods A total of 976 patients who underwent endoscopic treatment of CBDS were retrospectively studied. Risk factors for single and multiple recurrent CBDS were evaluated using a Cox hazard regression model. The incidences of further recurrences were evaluated according to the additional interventions. Results The mean age was 69.3 years, and 39.3% were female. Endoscopic papillary balloon dilation, endoscopic sphincterotomy, and endoscopic papillary large balloon dilation were performed in 858, 77, and 41 patients, respectively. The rates of one or more recurrence and multiple recurrences of CBDS were 12.4% and 2.7%, respectively. In the multivariate analyses, the significant risk factors were the bile duct size (hazard ratio [HR] 1.07, P = 0.012), gallbladder left in situ with stones (HR 1.91, P = 0.046), and pneumobilia after treatment (HR 2.10, P = 0.047) for single recurrence and the number of stones at the first recurrence (HR 1.16, P = 0.021) for multiple recurrences. In five out of nine cases with multiple recurrences, further recurrence was not observed after additional sphincteroplasty in addition to cholecystectomy. Conclusions The incidence of multiple recurrences was not uncommon after the first recurrence of CBDS.
Background and Aim When endoscopic retrograde cholangiopancreatography (ERCP) fails in patients with malignant distal biliary obstruction, endoscopic ultrasound‐guided choledochoduodenostomy (EUS‐CDS) is an alternative. It has high technical and clinical success rates, but also has high adverse event rates. This prospective cohort study was aimed to evaluate the clinical efficacy and safety of EUS‐CDS with our newly developed partially covered self‐expandable metal stent with a thin delivery system. Methods Patients consisted of all consecutive patients in three tertiary referral centers with unresectable malignant distal obstruction in whom ERCP failed and in whom EUS‐CDS with the thin delivery system was selected as the second‐line approach. Rates of clinical success, technical success, technical success in cases not requiring fistulous tract dilation, adverse events, and stent dysfunction were determined. Results In the 20 patients, technical and clinical success rates were 95.0% (19/20) and 100% (19/19), respectively. In 31.6% (6/19), the delivery system was successfully inserted into the bile duct without requiring a fistulous‐tract dilatation device. These patients had significantly shorter procedure times than patients requiring fistulous‐tract dilatation (12.7 ± 3.1 vs 23.2 ± 2.1 min; P < 0.01). One patient (5.0%) who required fistulous dilation had an adverse event, which was managed conservatively. There were no procedure‐related deaths. During follow up, four patients (21.1%) developed stent dysfunction. Reintervention was successful in all cases. Conclusions The EUS‐CDS approach had 95% technical and 100% clinical success rates, with adverse events reported in 5% of cases. EUS‐CDS may become safer if efforts are made to avoid the dilation step (UMIN 000023938).
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