Is EUS-guided drainage a suitable alternative technique in case of proximal biliary obstruction?
ABSTRACT: Results of endoscopic ultrasound-guided biliary drainage (EUBD) are unknown in case of proximal stricture. The aim is to assess clinical outcomes of EUBD in patients with malignant hilar obstruction.Patients undergoing EUBD with hilar strictures were prospectively included. Primary outcome was clinical success at 7 and 30 days (defined by 50% bilirubin decrease). Secondary outcomes were technical success, procedure-related complications, length of hospital stay, reintervention rate, survival and chemotherapy administration.Eighteen patients with a mean age of 68.8 years were included. On 15 classable stenosis, 7 (47%) were noted Bismuth I-II, 7 (47%) Bismuth III, and 1 (6.7%) Bismuth IV. Reasons for EUBD were surgically modified anatomy in 10 patients (55.6%), impassable stricture at ERCP in 7 (38.9%) and duodenal obstruction in 1 (5.6%). Only hepaticogastrostomy was performed. Clinical success was at day 7 and 30 respectively 72.2% and 68.8%. Technical success was 94%. Complications occurred in 3 (16.7%) patients. Median (range) length of hospital stay was 10 (6-35) days. Reintervention rate was 16.7%. Median (range) survival was 79 (5-390) days. Chemotherapy was possible in 10 (55.6%) patients.EUBD is feasible for hilar obstruction for surgically altered anatomy or after ERCP failure. Clinical outcome is satisfactory when considering underlying advanced disease, allowing chemotherapy.
Project description:Endoscopic treatment of benign biliary strictures (BBS) can be challenging.To evaluate the efficacy of fully covered self-expandable metal stents (FCSEMS) in BBS.Ninety-two consecutive patients with BBS (chronic pancreatitis (n?=?42), anastomotic after liver transplantation (n?=?36), and post biliary surgical procedure (n?=?14)) were included. FCSEMS were placed across strictures for 6 months before endoscopic extraction. Early success rate was defined as the absence of biliary stricture or as a minimal residual anomaly on post-stent removal endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes were the final success and stricture recurrence rates as well as procedure-related morbidity.Stenting was successful in all patients. Stenting associated complications were minor and occurred in 22 (23.9%) patients. Migration occurred in 23 (25%) patients. Stent extraction was successful in all but two patients with proximal stent migration. ERCP after the 6 months stenting showed an early success in 84.9% patients (chronic pancreatitis patients: 94.7%, liver transplant: 87.9%, post-surgical: 61.5%) (p?=?0.01). Final success was observed in 57/73 (78.1%) patients with a median follow-up of 12?±?3.56 months. Recurrence of biliary stricture occurred in 16/73 (21.9%) patients.FCSEMS placement is efficient for patients with BBS, in particular for chronic pancreatitis patients. Stent extraction after 6 months indwelling, although generally feasible, may fail in a few cases.
Project description:INTRODUCTION:Data about the efficacy of palliative double stenting for malignant duodenal and biliary obstruction are limited. METHODS:A systematic literature search was performed to assess the feasibility and optimal method of double stenting for malignant duodenobiliary obstruction compared with surgical double bypass in terms of technical and clinical success, adverse events, reinterventions, and survival. Event rates with 95% confidence intervals were calculated. RESULTS:Seventy-two retrospective and 8 prospective studies published until July 2018 were included. Technical and clinical success rates of double stenting were 97% (95%-99%) and 92% (89%-95%), respectively. Clinical success of endoscopic biliary stenting was higher than that of surgery (97% [94%-99%] vs 86% [78%-92%]). Double stenting was associated with less adverse events (13% [8%-19%] vs 28% [19%-38%]) but more frequent need for reintervention (21% [16%-27%] vs 10% [4%-19%]) than double bypass. No significant difference was found between technical and clinical success and reintervention rate of endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic drainage, and endoscopic ultrasound-guided biliary drainage. ERCP was associated with the least adverse events (3% [1%-6%]), followed by percutaneous transhepatic drainage (10% [0%-37%]) and endoscopic ultrasound-guided biliary drainage (23% [15%-33%]). DISCUSSION:Substantially high technical and clinical success can be achieved with double stenting. Based on the adverse event profile, ERCP can be recommended as the first choice for biliary stenting as part of double stenting, if feasible. Prospective comparative studies with well-defined outcomes and cohorts are needed.
Project description:Endoscopic drainage of complex hilar tumors has generally resulted in poor outcomes. Drainage of >50% of liver volume has been proposed as optimal, but not evaluated using long multifenestrated plastic stents (MFPS) or self-expanding metal stents (SEMS). We evaluated outcomes of endoscopic drainage of malignant hilar strictures using optimal strategy and stents, and determined factors associated with stent patency, survival, and complications.Cross-sectional study was conducted at an academic center over 5 years. MFPS (10 French or 8.5 French) or open-cell SEMS were used for palliation of unresectable malignant hilar strictures, with imaging-targeted drainage of as many sectors as needed to drain >50% of viable liver volume. Risk factors were evaluated using regression analysis. The cumulative risk was assessed using Kaplan-Meier analysis.77 patients with malignant hilar biliary strictures (median Bismuth IV) underwent targeted stenting (41 MFPS and 36 SEMS). Comparing MFPS vs. SEMS, technical success (95.1 vs. 97.2%, P=0.64), clinical success (75.6 vs. 83.3%, P=0.40), frequency of multiple stents (23/41 vs. 25/36, P=0.19), survival and adverse events were similar, but stent patency was significantly shorter (P<0.0001). Factors associated with survival were Karnofsky score and serum bilirubin level at presentation. Outcomes were independent of Bismuth class with acceptable results in Bismuth III and IV.Endoscopic biliary drainage with MFPS or open-cell SEMS targeting >50% of viable liver resulted in effective palliation in patients with complex malignant hilar biliary strictures. Patency was shorter in the MFPS group, but similar survival and complications were found when comparing MFPS and SEMS group.
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: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 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: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 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:Endobiliary brushing during endoscopic retrograde cholangiopancreatography (ERCP) is the main technique used to diagnose a malignant stricture, but has a poor sensitivity. This study evaluated the diagnostic performance of bile aspiration associated with biliary brushing during ERCP to diagnose a malignant stricture, compared to brushing alone.Between January 2007 and December 2012, all consecutive patients undergoing ERCP to treat a biliary stricture were included. After a biliary sphincterotomy, 3 mL to 10 mL of bile was aspirated into the brush catheter and collected in a dry sterile tube before and after brushing (to yield three samples). Brushing was performed as commonly recommended.One hundred eleven patients (68 males, 43 females) were included; mean age 67 ± 15.4 years. A final diagnosis of malignant stricture was established in 51 patients, including 43 cholangiocarcinomas; 60 patients had benign strictures. Specificity (Sp) and positive predictive values were 100% for all samples. The diagnostic performance of the three-sample combination of bile aspiration + brushing + bile aspiration was significantly greater than brushing alone (P = 0.004): sensitivity (Se) = 84.3 % vs. Se = 66.7 %. The three-sample combination gave a negative predictive value of 88.2 %, and a diagnostic accuracy of 92.8 %. When suspicious results were added to malignant results as positive results, the three-sample combination gave Sp = 91.7 % and Se = 94.1 %.In cases of biliary stricture, conducting bile aspiration before and after brushing significantly increased the ability to diagnose a malignant stricture with a sensitivity of 84.3 % (P = 0.004).
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.