EUS-guided antegrade metal stenting with hepaticoenterostomy using a dedicated plastic stent with a review of the literature (with video).
ABSTRACT: 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: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:Postsurgical benign bilioenteric anastomotic strictures are a major adverse event of biliary surgery and endoscopic treatment, including endoscopic retrograde cholangiopancreatography (ERCP), is challenging in this setting. We present an innovative approach to treating this complication.Patients underwent endoscopic ultrasound (EUS)-hepaticogastrostomy (HG) to treat nonmalignant biliary obstructions. A first endoscopy was performed to create the hepaticogastrostomy and to drain the biliary tree. The second step had a therapeutic purpose: antegrade dilation of the anastomosis.Four men and three women with benign bilioenteric anastomotic strictures were included. Patients presented with jaundice or recurrent cholangitis. A fully covered HG stent was successfully deployed during the first endoscopy. During the second step, repeat antegrade dilation was performed through the HG in four cases (1 - 4 dilations) followed by double pigtail stenting in three cases. In three other patients, the stenosis was not crossable and a double pigtail stent was placed to maintain biliary drainage. All patients had symptom relief at the end of follow-up (45 weeks, range 33 - 64).Dilation of anastomotic stenosis through a hepaticogastrostomy is feasible and may provide permanent biliary drainage or recurrent access to the biliary tree in patients with altered anatomy. Double pigtail stents might prevent migration.
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: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: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: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: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:BACKGROUND AND STUDY AIMS?:Stent insertion at endoscopic retrograde cholangiopancreatography (ERCP) is an established therapy for managing malignant biliary obstruction. Conventional plastic stents with a tubular design are most commonly used despite limited patency. Plastic stents with a winged design may theoretically increase the duration of stent patency. The aim of this study was to compare stent patency of the winged versus conventional plastic stents in patients with malignant biliary obstruction. PATIENTS AND METHODS?:A prospective, randomized subject-blinded trial was conducted. Patients with malignant biliary obstruction were randomized (1:1) to either a 10 French winged stent or 7 or 10 French conventional plastic stent. Strictures greater than 1?cm distal to the hilum were included. Patients were followed clinically to determine the frequency of stent failure until surgery, death or study closure. RESULTS?:Fifty-eight patients were enrolled. Following 9 exclusions, 49 patients were randomized to a winged (n?=?23) or conventional stent (n?=?26). Median time to stent failure was 89 (95?% CI 26-NA) vs 143 (95?% CI 33?-?266) days ( P ?=?0.963) for the winged and conventional group, respectively. Stent failure for the winged group occurred in 11 (48?%) compared to 14 (54?%) in the conventional group.?Median survival was 123 (95?% CI 81?-?189) vs 342 days (95?% CI 123?-?704) (p?=?0.084) in the winged and conventional group respectively. There were no procedure related adverse events. CONCLUSIONS?:Improvement in stent patency was not seen with the winged stent when compared to the conventional plastic stent.
Project description:BACKGROUND:To overcome duodenobiliary reflux induced by biliary stents, antireflux valve (ARV) biliary stents have been developed and showed improvement in stent patency. However, negative study results have also been reported because stent patency may be decreased by the malfunction of ARV itself. Given such mixed results, the true efficacy of ARV remains unknown and the mechanism of its dysfunction needs to be clearly elucidated. The aim of this study was to investigate the exact mechanism of ARV dysfunction using in vitro phantom models. METHODS:Two experimental models were designed to evaluate two important environmental factors suspected to cause ARV malfunction, i.e. bile flow and pH. Three types of ARV metal stents from different companies were used for the experiments: a funnel type ARV, a windsock type ARV, and a wine glass-shaped ARV. Ten stents of each type were tested (five stents in the bile flow phantom model, and another five stents in the duodenal pH environmental model). To determine ARV malfunction, ARV-induced flow resistance was measured using a custom-made testing device. All stents from the two models were removed every 2 weeks for 12 weeks after stent insertion and were evaluated on morphological and functional changes of the ARV. RESULTS:Only ARV of wine glass-shaped ARV was morphologically changed due to silicone bond detachment in the bile flow model. All types of ARV were morphologically changed in the pH model. The morphological changes of ARV influenced the flow resistance. The antegrade pressure gradients were increased over time in the pH model (p?<?0.05). CONCLUSIONS:Morphological change of the ARVs may induce dysfunction of ARV metal stents, which is mainly due to duodenal pH environment. In the future, development of new ARV that is not affected by duodenal environmental factors can be expected to improve stent patency.
Project description:Endoscopic bile duct decompression using bilateral self-expandable metallic stents (SEMSs) deployed via a stent-in-stent (SIS) method is considered a preferred procedure for malignant hilar biliary obstruction (MHBO). However, occlusion thereof occurs frequently. Here, we investigated stent patency duration and risk factors related to stent obstruction with bilateral SIS placement for MHBO at two large centers.The present study reviewed data on patients with MHBO who underwent endoscopic biliary drainage using the SIS method. Clinical outcomes, including stent patency duration and patient overall survival, were analyzed. Factors associated with stent patency were evaluated using Cox proportional hazards models.Seventy patients with MHBO underwent endoscopic biliary drainage using the SIS method. Median age was 68 years old, and median follow-up duration was 140 days (interquartile range, 57-329). The proportion of high-grade MHBOs (Bismuth type IV) was 57.1%. Median stent patency duration with the SIS method was 108 days according to Kaplan-Meier curves. Median patient survival analyzed by the Kaplan-Meier method was 181 days. Multivariate analysis indicated that higher baseline bilirubin (> 6.1 mg/dL) as an independent risk factor related to stent patency (p<0.05).In endoscopic biliary decompression using SEMS placed with the SIS method, obstructive jaundice was a risk factor for stent patency. The SIS method for high-grade MHBO showed short stent patency.