Endoscopic ultrasound-guided biliary drainage for distal malignant obstruction: a systematic review and meta-analysis of randomized trials.
ABSTRACT: 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:Duodenal obstruction may prevent performance of endoscopic retrograde cholangiopancreatography (ERCP). Percutaneous transhepatic biliary drainage (PTBD) or Endoscopic ultrasonograhy-guided biliary access (EUS-BD) are alternative treatments but are associated with a higher morbidity and mortality rate. The aim of the study is to report overall technical success rate and clinical outcome with deployment of temporary fully or partially covered self-expanding duodenal stent (pc/fcSEMS) as a bridge to ERCP in case of inaccessible papilla due to duodenal strictures.This retrospective study included 66 consecutive patients presenting with a duodenal stricture impeding the ability to perform an ERCP. Provisional duodenal stenting was performed as a bridge to ERCP. A second endoscopic session was performed to remove the provisional stent and to perform an ERCP. Afterward, a permanent duodenal stent was delivered if necessary.Sixty-six duodenal stents (17 pcSEMS and 49 fcSEMS) were delivered with a median indwelling time of 3.15 (1 - 7) days. Two migrations occurred in the pcSEMS group, 1 of which required lower endoscopy for retrieval. No other procedure-related complications were observed. At second endoscopy a successful ERCP was performed in 56 patients (85 %); 10 patients (15 %) with endoscopic failure underwent PTBD or EUS-BD. Forty patients needed permanent duodenal stenting.Provisional removable covered duodenal stenting as a bridge to ERCP for duodenal obstruction is safe procedure and in most cases allows successful performance of therapeutic ERCP. This technique could be a sound option as a step up approach before referring such cases for more complex techniques such as EUS-BD or PTBD.
Project description:Background and Objectives:EUS-guided biliary drainage (EUS-BD) is a feasible procedure when ERCP fails, as is percutaneous transhepatic BD (PTBD). However, little is known about patient perception and preference of EUS-BD and PTBD. Patients and Methods:An international multicenter survey was conducted in seven tertiary referral centers. In total, 327 patients, scheduled to undergo ERCP for suspected malignant biliary obstruction, were enrolled in the study. Patients received decision aids with visual representation regarding the techniques, benefits, and adverse events (AEs) of EUS-BD and PTBD. Patients were then asked the choice between the two simulated scenarios (EUS-BD or PTBD) after failed ERCP, the reasons for their preference, and whether altering AE rates would influence their prior choice. Results:In total, 313 patients (95.7%) responded to the questionnaire and 251 patients (80.2%) preferred EUS-BD. The preference of EUS-BD was 85.7% (186/217) with EUS-BD expertise, compared to 67.7% (65/96) without EUS-BD expertise (P < 0.001). The main reason for choosing EUS-BD was the possibility of internal drainage (78.1%). In multivariate analysis, the availability of EUS-BD expertise was the single independent factor that influenced patient preference (odds ratio: 3.168; 95% of confidence interval, 1.714-5.856; P < 0.001). The preference of EUS-BD increased as AE rates decreased (P < 0.001). Conclusions:In this simulated scenario, approximately 80% of patients preferred EUS-BD over PTBD after failed ERCP. However, preference of EUS-BD declined as its AE rates increased. Further technical innovations and improved proficiency in EUS-BD for reducing AEs may encourage the use of this procedure as a routine clinical practice when ERCP fails.
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 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 study aims ?Although endoscopic retrograde cholangiopancreatography (ERCP) is standard of care for malignant biliary obstruction, endoscopic ultrasound-guided biliary drainage (EUS-BD) as a primary treatment has become increasingly utilized. The aim of this study was to perform a systematic review and meta-analysis to evaluate the effectiveness and safety of EUS-BD for primary treatment of malignant biliary obstruction and comparison to traditional ERCP. Methods ?Individualized search strategies were developed through November 2018 using PRISMA and MOOSE guidelines. A cumulative meta-analysis was performed by calculating pooled proportions. Subgroup analysis was performed for studies comparing EUS-BD versus ERCP. Heterogeneity was assessed with Cochran Q test or I 2 statistics, and publication bias by funnel plot and Egger's tests. Results ?Seven studies (n?=?193 patients; 57.5?% males) evaluating primary EUS-BD for malignant biliary obstruction were included. Mean age was 67.4 years (2.3) followed an average of 5.4 months (1.0). For primary EUS-BD, pooled technical success, clinical success, and adverse event (AE) rates were 95?% (95?% CI 91?-?98), 97?% (95?% CI 93?-?100), and 19?% (95?% CI 11?-?29), respectively. Among EUS-BD and ERCP comparator studies, technical and clinical success, and total AEs were not different with lower rates of post-ERCP pancreatitis and reintervention among the EUS-BD group. Conclusion ?Primary EUS-BD is an effective treatment with few AE. Comparing EUS-BD versus ERCP, EUS-BD has comparable efficacy and improved safety as a primary treatment for malignant biliary obstruction. Further randomized trials should be performed to identify patient populations and clinical scenarios in which primary EUS-BD would be most appropriate.
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: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) 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: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.
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.