International multicenter comparative trial of transluminal EUS-guided biliary drainage via hepatogastrostomy vs. choledochoduodenostomy approaches.
ABSTRACT: Endoscopic ultrasound-guided biliary drainage (EUS-BD) can be performed entirely transgastrically (hepatogastrostomy/EUS-HG) or transduodenally (choledochoduodenostomy/EUS-CDS). It is unknown how both techniques compare. The aims of this study were to compare efficacy and safety of both techniques and identify predictors of adverse events.Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EUS-BD at multiple international centers were included. Technical/clinical success, adverse events, stent complications, and survival were assessed.A total of 121 patients underwent EUS-BD (CDS 60, HG 61). Technical success was achieved in 112 (92.56 %) patients (EUS-CDS 93.3 %, EUS-HG 91.8 %, P = 0.75). Clinical success was attained in 85.5 % of patients who underwent EUS-CDS group as compared to 82.1 % of patients who underwent EUS-HG (P = 0.64). Adverse events occurred more commonly in the EUS-HG group (19.67 % vs. 13.3 %, P = 0.37). Both plastic stenting (OR 4.95, 95 %CI 1.41 - 17.38, P = 0.01) and use of non-coaxial electrocautery (OR 3.95, 95 %CI 1.16 - 13.40, P = 0.03) were independently associated with adverse events. Length of hospital stay was significantly shorter in the CDS group (5.6 days vs. 12.7 days, P < 0.001). Mean follow-up duration was 151 ± 159 days. The 1-year stent patency probability was greater in the EUS-CDS group [0.98 (95 %CI 0.76 - 0.96) vs 0.60 (95 %CI 0.35 - 0.78)] but overall patency was not significantly different. There was no difference in median survival times between the groups (P = 0.36) CONCLUSIONS: Both EUS-CDS and EUS-HG are effective and safe techniques for the treatment of distal biliary obstruction after failed ERCP. However, CDS is associated with shorter hospital stay, improved stent patency, and fewer procedure- and stent-related complications. Metallic stents should be placed whenever feasible and non-coaxial electrocautery should be avoided when possible as plastic stenting and non-coaxial electrocautery were independently associated with occurrence of adverse events.
Project description:Endoscopic retrograde cholangiopancreatography (ERCP) with transpapillary metal stenting is the standard palliation method for malignant distal biliary obstruction (MDBO); however, post-ERCP pancreatitis are not uncommon. Endoscopic ultrasonography-guided biliary drainage (EUS-BD) with transmural metal stenting has emerged as an option for primary palliation of MDBO. We compared the efficacy and safety of these procedures as first-line MDBO treatment. We searched for relevant English-language articles in PubMed, Embase, and Cochrane databases. The outcomes of interest were technical success, clinical success, adverse events, stent patency, reintervention rates, and procedure time. Subgroup analysis was performed for patients without duodenal invasion (eg, endoscopically accessible papilla; EUS-choledochoduodenostomy [CDS] vs. ERCP). Ten studies (3 randomized trials and 7 retrospective studies) with 756 patients were included. The cumulative technical and clinical success rates were high for both procedures (EUS-BD: 94.8% [294/310] and 93.8% [286/305], ERCP: 96.5% [386/400] and 95.7% [377/394]). The cumulative adverse event rates were 16.3% (54/331) for EUS-BD and 18.3% (78/425) for ERCP. In subgroup analysis for patients without duodenal invasion, EUS-CDS showed similar cumulative technical and clinical success rate with ERCP (technical success rate, EUS-CDS vs. ERCP: 94.2% [146/155] vs. 97.8% [237/242]; clinical success rate, EUS-CDS vs. ERCP: 94.2% [145/154] vs. 93.0% [225/242]). The cumulative rate of adverse events for EUS-CDS and ERCP was also comparable (15.5% [24/155] for EUS-CDS and 18.6% [45/242] for ERCP). As first-line palliation of MDBO, EUS-BD was similar to ERCP in technical and clinical success and safety; however, larger randomized trials comparing EUS-CDS and ERCP in this setting with endoscopically accessible papilla may be required.
Project description:Endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures after failed endoscopic retrograde cholangiopancreatography (ERCP). However, prospective multicenter data are lacking. The aims of this study were to prospectively assess the short- and long-term efficacy and safety of EUS-BD in patients with malignant distal biliary obstruction.Consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal biliary obstruction and failed ERCP underwent EUS-BD. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as a reduction in bilirubin by 50 % at 2 weeks or to below 3 mg/dL at 4 weeks. Adverse events were prospectively tracked and graded according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon's severity grading system. Overall survival and duration of stent patency were calculated using Kaplan-Meier analysis.A total of 96 patients (mean age 66 years, female 45 %, pancreatic cancer 55 %) underwent EUS-BD. Stent placement (technical success) was achieved in 92 (95.8 %) patients (metallic stent 84, plastic stent 8). Mean procedure time was 40 minutes. Clinical success was achieved in 86 (89.5 %) patients. A total of 10 (10.5 %) adverse events occurred: pneumoperitoneum (n = 2), sheared wire (n = 1), bleeding (n = 1), bile leak (n = 3), cholangitis (n = 2), and unintentional perforation (n = 1); 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). A total of 38 (44 %) patients died of disease progression during the study period. The median patient survival was 167 days (95 %CI 112 - 221) days. The 6-month stent patency rate was 95 % (95 %CI 94.94 - 95.06 %) and the 1-year stent patency was 86 % (95 %CI 85.74 - 86.26 %).This study on EUS-BD demonstrates excellent efficacy and safety of EUS-BD when performed by experts.NCT01889953.
Project description:Background and Objectives:Recently, a novel EUS-guided biliary drainage (EUS-BD) technique consisting of EUS-guided antegrade stenting and EUS-guided hepaticoenterostomy (EUS-AS+HES) using two conventional metal stents (MS) has been reported to decrease adverse events and maintain longer stent patency for malignant biliary obstruction (MBO). However, only a few limited reports have evaluated this technique. Finally, dedicated plastic stents (PSs) have been developed to perform EUS-HES safely. The aim of the present study was to evaluate the outcome in EUS-AS+HES for MBO using the dedicated HES PSs. Methods:The results of a total of 23 patients who underwent EUS-AS+HES (18 simultaneous cases and 5 sequential cases) for MBO from October 2014 to July 2017 were retrospectively reviewed. Results:Technical and clinical success rates were 100% (23/23). Adverse events were seen in 8.7% (2/23); 2 cases of mild biliary peritonitis, which were successfully managed conservatively. Overall survival was 96 days and the median duration of stent patency, including stent dysfunction, patient death, and last follow-up, was 66.0 days (53 days in simultaneous cases and 78 days in sequential cases). Stent dysfunction was seen in 13.0% (3/23) of patients in 267, 263, and 135 days after the procedure. Conclusions:The novel EUS-BD technique, EUS-AS using MS plus HES employing a dedicated PS, was shown to be a feasible procedure for MBO and should yield longer duration of stent patency. Furthermore, sequential antegrade stenting in cases of occluded HES seems to be one other option instead of HES stent exchange. Further large-scale comparison studies with EUS-HES or EUS-AS are required to confirm its clinical efficacy.
Project description:Background and Objectives:Biliary drainage (BD) under EUS guidance is usually indicated for malignant biliary obstruction. Recently, EUS-guided transluminal treatment has been applied to benign biliary disease (BBD). This multicenter retrospective study evaluated the clinical impact of EUS-guided transluminal stent deployment for BBD with long-term follow-up. Patients and Methods:This retrospective study investigated patients treated between September 2015 and October 2016 at participating hospitals in the therapeutic endoscopic group. The inclusion criteria comprised complications with BBD obstructive jaundice or cholangitis and failed endoscopic retrograde cholangiopancreatography or inaccessible ampulla of Vater. Results:Twenty-six patients underwent EUS-guided transluminal stent deployment. Indications for EUS-guided transluminal stent deployment comprised anastomotic biliary stricture (n = 17), bile duct stones (n = 5), inflammatory biliary stricture (n = 3), and acute pancreatitis prevention (n = 1). Thirteen of these 26 patients underwent scheduled reintervention, with technical success achieved in all 13 patients. None of the deployed stents became dysfunctional. Among the 13 patients who underwent reintervention on demand, stents had become dysfunctional in six patients (stent patency: 48, 90, 172, 288, 289, and 608 days). Reintervention was successfully performed in all patients. During follow-up (median, 749 days), severe adverse events were not seen in any patients. Conclusion:We concluded that EUS-guided transluminal stent deployment for BBD is feasible and safe. Because metal stent dysfunction was more frequent when deployed on demand, such stents should be exchanged for plastic stents in a scheduled manner if a metal stent is used.
Project description:INTRODUCTION:Current evidence supporting the utility of endoscopic ultrasound-guided biliary drainage (EUS-BD) as a first-line treatment option for malignant biliary obstruction (MBO) is limited. We plan to provide a systematic review and meta-analysis to compare the performance of EUS-BD and endoscopic retrograde cholangiopancreatography-guided biliary drainage (ERCP-BD) as primary palliation of MBO. METHODS AND ANALYSIS:Randomised controlled trials evaluating EUS-BD versus ERCP-BD in primary drainage of MBO will be searched in MEDLINE, EMBASE, Web of Science, the Cochrane Library, ClinicalTrials.gov and Google Scholar, from database inception to 31 October 2018. Data on study design, participant characteristics, intervention details and outcomes will be extracted. Primary outcomes to be assessed are technical and clinical success. Secondary outcomes include adverse events, stent patency, stent dysfunction, reinterventions, procedure duration and overall survival. Study quality will be assessed using the Cochrane Risk of Bias Tool. Meta-analysis will be performed using RevMan V.5.3 statistical software. Data will be combined with a random effect model. The results will be presented as a risk ratio for dichotomous data, weighted mean difference for continuous data and HR for time-to-event data. Publication bias will be visualised using funnel plots. ETHICS AND DISSEMINATION:This study will not use primary data, and therefore, formal ethical approval is not required. The findings will be disseminated through peer-reviewed journals and committee conferences. PROSPERO REGISTRATION NUMBER:CRD42018117040.
Project description:Background and study aims ?Endoscopic ultrasound (EUS)-guided biliary drainage (BD) is increasingly used for distal malignant biliary obstruction, yet its safety and efficacy compared to endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD) remain unclear. We performed a meta-analysis to improve our understanding of the role of EUS-BD in this patient population. Methods ?We searched Embase, MEDLINE, CENTRAL, and ISI Web of Knowledge through September 2018 for randomized controlled trials (RCTs) comparing EUS-BD to ERCP-BD or PTBD as treatment of distal malignant biliary obstruction. Risk ratios (RRs) with 95?% confidence intervals (CIs) were combined using random effects models. The primary outcome was risk of stent/catheter dysfunction requiring reintervention. Results ?Of six trials identified, three (n?=?222) compared EUS-BD to ERCP-BD for first-line therapy; three others (n?=?132) evaluated EUS-BD versus PTBD after failed ERCP-BD. EUS-BD was associated with a decreased risk of stent/catheter dysfunction overall (RR, 0.39; 95?%CI 0.27?-?0.57) and in planned subgroup analysis when compared to ERCP (RR, 0.41; 95?%CI 0.23?-?0.74) or PTBD (RR, 0.37, 95?%CI 0.22?-?0.61). Compared to ERCP, EUS was associated with a decreased risk of post-procedure pancreatitis (RR, 0.12; 95?%CI 0.01?-?0.97). No differences were noted in technical or clinical success. Conclusions ?In a meta-analysis of randomized trials comparing EUS-BD to conventional biliary drainage modalities, no difference in technical or clinical success was observed. Importantly, EUS-BD was associated with decreased risks of stent/catheter dysfunction when compared to both PTBD and ERCP, and decreased post-procedure pancreatitis when compared to ERCP, suggesting the potential role for EUS-BD as an alternative first-line therapy in distal malignant biliary obstruction.
Project description:BACKGROUND & AIMS:Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction. METHODS:The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. DISCUSSION:The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design. TRIAL REGISTRATION:Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.
Project description:Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been increasingly reported as an alternative to percutaneous transhepatic biliary drainage in failed endoscopic retrograde cholangiopancreatography. Moreover, conversion to EUS-BD can be a good alternative when transpapillary biliary drainage is technically possible but complicated by cholangitis because EUS-BD enables one-step internal drainage not traversing the tumor. Herein, we report a case of recurrent cholangitis due to hemobilia and cholecystitis due to tumor involvement to the cystic duct after transpapillary stent placement, which was successfully managed by conversion to EUS-BD and EUS-guided gallbladder drainage in one session.
Project description:Background Endoscopic ultrasound-guided biliary drainage (EUS-BD) is used after failed endoscopic retrograde cholangiopancreatography. Based on existing studies, intrahepatic (IH) approaches are preferred in patients with dilated IH bile ducts. Both ultrasound-guided hepaticogastrostomy (EUS-HGS) and ultrasound-guided antegrade treatment (EUS-AG) are appropriate for patients with unreachable papillae. Nevertheless, there have been no direct comparisons between these two approaches. Therefore, we aim to evaluate and compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. Methods This is a prospective, randomised, controlled, multicentre study with two parallel groups without masking. One hundred forty-eight patients from three hospitals who met the inclusion criteria will be randomly assigned (1:1) to undergo either EUS-HGS or EUS-AG for relief of malignant biliary obstruction. The final study follow-up is scheduled at 1?year postoperatively. The primary endpoint is efficiency, described by technical and clinical success rates of EUS-HGS and EUS-AG in patients with unreachable papillae. The secondary endpoints include stent patency, overall survival rates, complication rates, length of hospital stays, and hospitalisation expenses. The chi-square test, Kaplan–Meier methods, log-rank test, and Cox regression analysis will be used to analyse the data. Discussion To our knowledge, this is the first study to compare these two EUS-BD approaches directly using a multicentre, randomised, controlled trial design. The clinical economic indexes will also be compared, as they may also affect the patient’s choice. The result may contribute to establishing a strategic guideline for choosing IH EUS-BD approaches. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR1900020737. Registered on 15 January 2019
Project description:ERCP is the current procedure of choice for patients with jaundice caused by biliary obstruction. EUS-guided biliary drainage (EUS-BD) has emerged as an alternative to ERCP in patients requiring biliary drainage. The aim of the study was to conduct a systematic review and meta-analysis to report the overall efficacy and safety of EUS-BD. We conducted a comprehensive search of several databases including PubMed, EMBASE, Web of Science, Google Scholar, and LILACS databases (earliest inception to June 2018) to identify studies that reported EUS-BD in patients. The primary outcome was to look at the technical and clinical success of the procedure. The secondary analysis focused on calculating the pooled rate of re-interventions and all adverse-events, along with the commonly reported adverse-event subtypes. Twenty-three studies reporting on 1437 patients were identified undergoing 1444 procedures. Majority of the patient population were male (53.86%), with an average age of 67.22 years. The pooled technical success rates and clinical success rates were 91.5% (95% confidence interval [CI]: 87.7-94.2, I = 76.5) and 87% (95% CI: 82.3-90.6, I = 72.4), respectively. The total adverse event rates were 17.9% (95% CI: 14.3-22.2, I = 69.1). Subgroup analysis of three major individual adverse events was bile leak: 4.1% (2.7-6.2, I = 46.7), stent migration: 3.9% (2.5-6.2, I = 43.5), and infection: 3.8% (2.8-5.1, I = 0) Substantial heterogeneity was noted in the analysis. EUS-BD has high technical and clinical success rate and hence a very effective procedure. Concerns about publication bias exist. Careful consideration should be given to the adverse events and weighing the risks and benefits of the alternative nonsurgical/surgical approaches.