Produção Nacional
Revisado por pares
EUS-guided biliary drainage
2015; Elsevier BV; Volume: 82; Issue: 6 Linguagem: Inglês
10.1016/j.gie.2015.06.043
ISSN1097-6779
AutoresMouen A. Khashab, Michael J. Levy, Takao Itoi, Everson L.A. Artifon,
Tópico(s)Pancreatic and Hepatic Oncology Research
ResumoIn patients with native upper GI anatomy, selective biliary cannulation by expert endoscopists is successful in more than 90% of procedures. When bile duct access cannot be obtained as a result of failed cannulation, altered anatomy, ampullary distortion or diverticulum, gastric outlet obstruction (GOO), or in situ duodenal stents, EUS-guided biliary drainage (EUS-BD) is increasingly used as an alternative to interventional radiology or surgery. Wiersema et al,1Wiersema M. Sandusky D. Carr R et al.Endosonography-guided cholangiopancreatography.Gastrointest Endosc. 1996; 44: 102-106Abstract Full Text Full Text PDF PubMed Scopus (252) Google Scholar in 1996, were the first to report the use of EUS-guided cholangiography in 7 patients who underwent successful EUS-guided cholangiography after failed ERCP. In 2001, Giovannini et al2Giovannini M. Moutardier V. Pesenti C. et al.Endoscopic ultrasound-guided bilioduodenal anastomosis: a new technique for biliary drainage.Endoscopy. 2001; 33: 898-900Crossref PubMed Scopus (543) Google Scholar reported the first experience with EUS-guided choledochoduodenostomy (CDS) placing a plastic stent in a patient with unresectable pancreatic cancer. Mallery et al,3Mallery S. Matlock J. Freeman M.L. EUS-guided rendezvous drainage of obstructed biliary and pancreatic ducts: report of 6 cases.Gastrointest Endosc. 2004; 59: 100-107Abstract Full Text Full Text PDF PubMed Scopus (332) Google Scholar in 2004, introduced the EUS-guided rendezvous (RV) approach, and subsequently multiple investigators have reported a variety of technical alternatives and outcomes of EUS-BD.4Kahaleh M. Hernandez A.J. Tokar J. et al.Interventional EUS-guided cholangiography: evaluation of a technique in evolution.Gastrointest Endosc. 2006; 64: 52-59Abstract Full Text Full Text PDF PubMed Scopus (265) Google Scholar, 5Maranki J. Hernandez A.J. Arslan B. et al.Interventional endoscopic ultrasound-guided cholangiography: long-term experience of an emerging alternative to percutaneous transhepatic cholangiography.Endoscopy. 2009; 41: 532-538Crossref PubMed Scopus (126) Google Scholar, 6Kim Y.S. Gupta K. Mallery S. et al.Endoscopic ultrasound rendezvous for bile duct access using a transduodenal approach: cumulative experience at a single center. A case series.Endoscopy. 2010; 42: 496-502Crossref PubMed Scopus (112) Google Scholar, 7Fabbri C. Luigiano C. Fuccio L. et al.EUS-guided biliary drainage with placement of a new partially covered biliary stent for palliation of malignant biliary obstruction: a case series.Endoscopy. 2011; 43: 438-441Crossref PubMed Scopus (52) Google Scholar, 8Komaki T. Kitano M. Sakamoto H. et al.Endoscopic ultrasonography-guided biliary drainage: evaluation of a choledochoduodenostomy technique.Pancreatology. 2011; 11: 47-51Abstract Full Text PDF PubMed Scopus (44) Google Scholar, 9Park D.H. Jang J.W. Lee S.S. et al.EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results.Gastrointest Endosc. 2011; 74: 1276-1284Abstract Full Text Full Text PDF PubMed Scopus (229) Google Scholar, 10Hara K. Yamao K. Niwa Y. et al.Prospective clinical study of EUS-guided choledochoduodenostomy for malignant lower biliary tract obstruction.Am J Gastroenterol. 2011; 106: 1239-1245Crossref PubMed Scopus (130) Google Scholar, 11Iwashita T. Lee J.G. Shinoura S. et al.Endoscopic ultrasound-guided rendezvous for biliary access after failed cannulation.Endoscopy. 2012; 44: 60-65Crossref PubMed Scopus (114) Google Scholar, 12Khashab M.A. Fujii L.L. Baron T.H. et al.EUS-guided biliary drainage for patients with malignant biliary obstruction with an indwelling duodenal stent (with videos).Gastrointest Endosc. 2012; 76: 209-213Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar, 13Henry W.A. Singh V.K. Kalloo A.N. et al.Simultaneous EUS-guided transbulbar pancreaticobiliary drainage (with video).Gastrointest Endosc. 2012; 76: 1065-1067Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar, 14Dhir V. Bhandari S. Bapat M. et al.Comparison of EUS-guided rendezvous and precut papillotomy techniques for biliary access (with videos).Gastrointest Endosc. 2012; 75: 354-359Abstract Full Text Full Text PDF PubMed Scopus (152) Google Scholar, 15Shah J.N. Marson F. Weilert F. et al.Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla.Gastrointest Endosc. 2012; 75: 56-64Abstract Full Text Full Text PDF PubMed Scopus (179) Google Scholar EUS-BD is performed by using 1 of 3 basic approaches that include the RV technique, transluminal (TL) stenting,16Itoi T. Yamao K. EUS 2008 Working Group document: evaluation of EUS-guided choledochoduodenostomy (with video).Gastrointest Endosc. 2009; 69: S8-S12Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar, 17Savides T.J. Varadarajulu S. Palazzo L. EUS 2008 Working Group document: evaluation of EUS-guided hepaticogastrostomy.Gastrointest Endosc. 2009; 69: 3-7Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar and EUS-guided antegrade transpapillary (or transanastomotic) biliary stent placement.18Artifon E.L. Safatle-Ribeiro A.V. Ferreira F.C. et al.EUS-guided antegrade transhepatic placement of a self-expandable metal stent in hepatico-jejunal anastomosis.JOP. 2011; 12: 610-613PubMed Google Scholar, 19Nguyen-Tang T. Binmoeller K.F. Sanchez-Yague A. et al.Endoscopic ultrasound (EUS)-guided transhepatic anterograde self-expandable metal stent (SEMS) placement across malignant biliary obstruction.Endoscopy. 2010; 42: 232-236Crossref PubMed Scopus (120) Google Scholar A linear echoendoscope is used to obtain biliary access ideally within a dilated segment of the bile duct proximal to the site of obstruction. The tip of the echoendoscope is positioned within the gastric fundus or duodenal bulb to access the intrahepatic and extrahepatic bile duct, respectively. A 19- or 22-gauge FNA needle is used to puncture the bile duct, and then access is confirmed with EUS or with contrast injection and fluoroscopic confirmation. Generally speaking, a 19-gauge needle is usually preferable because it allows passage of larger guidewires and rapid infusion of contrast. A 0.035-, 0.025-, 0.021-, or 0.018-inch guidewire is advanced into the bile duct. When initially selecting a smaller caliber 0.021- or 0.018-inch guidewire, many opt to exchange it for a larger-caliber guidewire to facilitate subsequent tract dilation and stent placement. Use of smaller guidewires (eg, 0.025 inch instead of 0.035 inch) may decrease the risk of guidewire shearing because it allows for more space between the guidewire and the needle tip. The trajectory of the echoendoscope and needle is angled to facilitate antegrade guidewire passage through the obstructed segment and across the papilla to coil in the guidewire in the small bowel. When an ideal echoendoscope or needle trajectory cannot be achieved, the guidewire tends to inadvertently pass into the proximal rather than distal biliary tree. When this occurs, one may intentionally advance the guidewire into the proximal bile duct, which sometimes allows looping and subsequent transpapillary guidewire advancement. Once the guidewire is properly placed, the echoendoscope is removed, and a standard duodenoscope is inserted to retrieve the guidewire by using a biopsy cable or snare, thereby allowing standard endoscopic retrograde cholangiography and stent placement (over-the-wire technique).20Khashab M.A. Valeshabad A.K. Modayil R. et al.EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos).Gastrointest Endosc. 2013; 78: 734-741Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar Alternatively, one may cannulate along the RV guidewire (Fig. 1). Stent selection should be dictated by patient and procedural factors. The TL approach is performed by using only the echoendoscope. After achieving bile duct access as described previously, the puncture tract is dilated by using either a dilating catheter or balloon. Various devices may then be used to facilitate antegrade stent placement,21Kumbhari V. Tieu A.H. Khashab M.A. EUS-guided biliary drainage made safer by a combination of hepaticogastrostomy and antegrade transpapillary stenting.Gastrointest Endosc. 2015; 81: 1015-1016Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 22Saxena P. Kumbhari V. Zein M.E. et al.EUS-guided biliary drainage with antegrade transpapillary placement of a metal biliary stent.Gastrointest Endosc. 2015; 81: 1010-1011Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar with selection based on the patient’s anatomy and features of the obstructing pathology. The TL approach most commonly entails creation of choledochoduodenostomy or hepatogastrostomy. The CDS technique requires creation of a neofistula between the duodenum and extrahepatic bile duct. The extrahepatic bile duct is identified from the duodenal bulb by using the long echoendoscope position, which provides a stable echoendoscope and ideal access to the bile duct. It is important to select a trajectory and angle of biliary access that promotes guidewire advancement toward the hepatic confluence. After initial cholangiography and guidewire placement (Fig. 2), tract dilation can be achieved by using a needle-knife, cystotome, or bougie. The degree of dilation should be sufficient to allow stent insertion while avoiding excess dilation that risks biliary leak and stent migration. Placement of a fully covered self-expandable metal stent (SEMS) is favored over plastic stents to minimize the risk of migration as well as bile leak. The success of hepatogastrostomy (HGS) largely depends on identification of a dilated left hepatic duct within segment 2 or 3 of the liver as viewed from the gastric cardia or body. The presence of a large hiatal hernia sometimes mandates needle puncture from more distal aspects of the stomach. Bile duct access puncture, tract dilation, and stent placement are performed in similar fashion to CDS. A key measure to account for both metal stent foreshortening and movement of the stomach away from the liver during respiration during HGS is the need to leave more than 3 cm of the SEMS in the gastric lumen (Fig. 3). As for CDS, most favor the use of SEMS in preference to plastic stents when the diameter of the accessed intrahepatic duct allows. Placement of a partially covered stent may aid in avoiding obstruction of secondary ducts and may decrease the risk of stent migration. Ideal indications for the HGS include the presence of a proximal biliary stricture and/or after distal gastrectomy that prohibits access to the extrahepatic bile duct.5Maranki J. Hernandez A.J. Arslan B. et al.Interventional endoscopic ultrasound-guided cholangiography: long-term experience of an emerging alternative to percutaneous transhepatic cholangiography.Endoscopy. 2009; 41: 532-538Crossref PubMed Scopus (126) Google Scholar The initial steps for FNA biliary access, cholangiography, guidewire placement, and tract dilation are analogous to the aforementioned approaches. However, with the antegrade stenting technique, anterograde stent placement is performed by advancing the stent through the echoendoscope over the guidewire to traverse the stricture and then the papilla (ie, transpapillary) or anastomosis (transanastomotic) (Fig. 4).21Kumbhari V. Tieu A.H. Khashab M.A. EUS-guided biliary drainage made safer by a combination of hepaticogastrostomy and antegrade transpapillary stenting.Gastrointest Endosc. 2015; 81: 1015-1016Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 22Saxena P. Kumbhari V. Zein M.E. et al.EUS-guided biliary drainage with antegrade transpapillary placement of a metal biliary stent.Gastrointest Endosc. 2015; 81: 1010-1011Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar The type of stent should be dictated by patient and procedural factors. Data mostly from small retrospective series suggest that EUS-BD can be performed with high therapeutic success (87%) but is associated with a 10% to 20% risk of adverse events, most of which are mild to moderate in nature. Serious adverse events are rare but may occur.23Khashab M.A. Dewitt J. EUS-guided biliary drainage: Is it ready for prime time? Yes!.Gastrointest Endosc. 2013; 78: 102-105Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar Artifon et al24Artifon E.L. Aparicio D. Paione J.B. et al.Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage.J Clin Gastroenterol. 2012; 46 (768-4)Crossref PubMed Scopus (166) Google Scholar recently reported the first prospective, randomized study that compared EUS-BD with percutaneous transhepatic biliary drainage (PTBD) in 25 patients (13 EUS-CDS and 12 PTBD) with malignant biliary obstruction after failed ERCP. All procedures were technically and clinically successful in both groups, and the adverse event rate was similar for both approaches (P = .44): EUS-CDS (15.3%) and PTBD (25%). Cost was also similar in both groups. These data suggest that EUS-BD may provide an acceptable alternative to PTBD; however, large prospective studies are needed to verify their findings and to more clearly define the role, ideal patient cohort, and risks associated with both techniques. Shah et al15Shah J.N. Marson F. Weilert F. et al.Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla.Gastrointest Endosc. 2012; 75: 56-64Abstract Full Text Full Text PDF PubMed Scopus (179) Google Scholar reported their experience performing EUS-BD in the setting of surgically altered anatomy or failed ERCP. Of the 70 patients who underwent attempted EUS-BD, a cholangiogram could be obtained in 68 patients (97%) with 66 patients having cholangiographic findings indicating the need for therapeutic intervention. EUS-BD by using the RV technique was successful in 37 of 50 patients (74%). In the remaining 16 patients, direct EUS-guided interventions (HGS, CDS, and antegrade stenting) were successful in 13 patients (81%). Six adverse events occurred, most of which were managed conservatively. Recently, Park et al25Park do H. Jeong S.U. Lee B.U. et al.Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video).Gastrointest Endosc. 2013; 78: 91-101Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar reported their experience using EUS-BD by 1 endoscopist in 45 patients with either benign or malignant biliary obstruction at a tertiary center in South Korea. These authors previously reported a high adverse event rate (20%)9Park D.H. Jang J.W. Lee S.S. et al.EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results.Gastrointest Endosc. 2011; 74: 1276-1284Abstract Full Text Full Text PDF PubMed Scopus (229) Google Scholar for EUS-BD and aimed to determine whether a modified technique of “enhanced guidewire manipulation” could improve the procedural safety and efficacy. The modified approach included (1) optimizing the angle of bile duct access, (2) use of smaller-caliber guidewires to avoid shearing, (3) use of a 4F catheter to help direct the guidewire toward/through distal stricture/ampulla, and (4) preferential puncturing of a segment 2 intrahepatic duct to promote guidewire passage toward the hilum.25Park do H. Jeong S.U. Lee B.U. et al.Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video).Gastrointest Endosc. 2013; 78: 91-101Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar In this study, the 45 patients underwent same-session EUS-BD after failed ERCP, and technical success was achieved in 41 patients (91%). Functional success, defined by a decrease in cholestatic indices to less than 75% of pretreatment values within 1 month of the procedure, was achieved in 39 patients (95%). A total of 5 adverse events (11%) developed in 4 patients, including 1 each of pancreatitis, focal bile peritonitis, limited pneumoperitoneum, intraperitoneal stent migration, and biloma. In accordance with the American Society for Gastrointestinal Endoscopy lexicon’s severity grading system, mild and moderate adverse events developed in 3 and 1 patients, respectively.26Cotton P.B. Eisen G.M. Aabakken L. et al.A lexicon for endoscopic adverse events: report of an ASGE workshop.Gastrointest Endosc. 2010; 71: 446-454Abstract Full Text Full Text PDF PubMed Scopus (1392) Google Scholar To evaluate the primary study aim of Park et al25Park do H. Jeong S.U. Lee B.U. et al.Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video).Gastrointest Endosc. 2013; 78: 91-101Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar of whether advanced guidewire manipulation might decrease the adverse event rate to less than 20% (n = 11) as in their previous study that included 55 patients who underwent either EUS-CDS or EUS-HGS,9Park D.H. Jang J.W. Lee S.S. et al.EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results.Gastrointest Endosc. 2011; 74: 1276-1284Abstract Full Text Full Text PDF PubMed Scopus (229) Google Scholar it is important to evaluate potential reasons for adverse events in the 11 patients (graded as mild in 7 and moderate in 4). Interestingly, 9 of the 11 patients in whom an adverse event developed underwent fistula dilation by using a needle-knife, which was independently associated with the occurrence of adverse events (odds ratio 12.4, P = .01). In the more recent trial, fistula dilation with a needle-knife was used in only 5 patients. This finding may indicate the need to avoid needle-knife cautery for tract creation/dilation during EUS-BD. Our preference is to avoid both overly aggressive tract dilation and the use of noncoaxial electrocautery for tract dilation (ie, dilation with a needle-knife) whenever possible. Gupta et al27Gupta K. Perez-Miranda M. Kahaleh M. et al.Endoscopic ultrasound-assisted bile duct access and drainage: multicenter, long-term analysis of approach, outcomes, and complications of a technique in evolution.J Clin Gastroenterol. 2014; 48: 80-87Crossref PubMed Scopus (106) Google Scholar reported their long-term outcomes of a multicenter study using EUS-BD in 246 patients, by using an intrahepatic approach in 60%. Successful biliary drainage rates were similar for both the extrahepatic and intrahepatic approaches (84.3% vs 90.4%, respectively; P = .15). A higher clinical success rate was noted in malignant diseases compared with benign diseases (90.2% vs 77.3%, P = .02). Adverse events included pneumoperitoneum (5%), bleeding (11%), bile leak/peritonitis (10%), and cholangitis (5%) with similar rates reported regardless of approach or disease pathology. When considering the data, it is important to note that nearly all published studies originate from tertiary high-volume centers that employ highly qualified interventional endoscopists. We believe that these procedures should ideally be performed by endoscopists well trained in both ERCP and EUS and carried out at institutions where surgery and radiology backup are available to help manage failed interventions and/or adverse events. Although the RV technique is favored by many endoscopists because it avoids the creation of a permanent bilioenteric fistula and the need for fistulous tract dilation, which may result in bleeding, pneumoperitoneum, and pneumomediastinum, there are few data to determine how RV and TL techniques compare in terms of efficacy and safety. Khashab et al20Khashab M.A. Valeshabad A.K. Modayil R. et al.EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos).Gastrointest Endosc. 2013; 78: 734-741Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar compared both approaches in 35 patients who underwent EUS-BD (RV, 13; TL, 20) for malignant distal biliary obstruction and failed ERCP. Technical and clinical success was achieved in 33 of 35 patients (94%) and 32 of 33 patients (97.0%), respectively. The mean postprocedure bilirubin level was 1.38 mg/dL in the RV group and 1.33 mg/dL in the TL group (P = .88), and the duration of hospitalization was also similar for both groups (P = .23). Their adverse event rate was comparable for the RV and TL groups (15.4% vs 10%, P = .64). Long-term outcomes were similar between both groups with stent migration (n = 1) in the RV group at 62 days and stent occlusion (n = 1) in the TL group at 42 days post–EUS-BD. Their data suggest that both RV and TL techniques are equally effective and safe. There are at least 4 potential disadvantages to EUS-guided biliary rendezvous that merit discussion. First, successful completion of the rendezvous approach is reported in only 75% of patients, even among expert endoscopists often due to GOO or surgically altered anatomy.15Shah J.N. Marson F. Weilert F. et al.Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla.Gastrointest Endosc. 2012; 75: 56-64Abstract Full Text Full Text PDF PubMed Scopus (179) Google Scholar, 25Park do H. Jeong S.U. Lee B.U. et al.Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video).Gastrointest Endosc. 2013; 78: 91-101Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar A second shortcoming is the need to exchange the echoendoscope for a duodenoscope, during which time there is the tendency for guidewire displacement. A third limitation is prolonged procedure times that result from (1) the need to manipulate the guidewire through the site of obstruction and ampulla, (2) the need to exchange the echoendoscope for a duodenoscope, and and (3) subsequent retrograde biliary interventions. A final shortcoming of RV EUS-BD is the risk of acute pancreatitis because of manipulation of the papilla.6Kim Y.S. Gupta K. Mallery S. et al.Endoscopic ultrasound rendezvous for bile duct access using a transduodenal approach: cumulative experience at a single center. A case series.Endoscopy. 2010; 42: 496-502Crossref PubMed Scopus (112) Google Scholar, 11Iwashita T. Lee J.G. Shinoura S. et al.Endoscopic ultrasound-guided rendezvous for biliary access after failed cannulation.Endoscopy. 2012; 44: 60-65Crossref PubMed Scopus (114) Google Scholar, 15Shah J.N. Marson F. Weilert F. et al.Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla.Gastrointest Endosc. 2012; 75: 56-64Abstract Full Text Full Text PDF PubMed Scopus (179) Google Scholar Our experience suggests that TL stenting is a safe alternative to RV EUS-BD when biliary drainage is successfully achieved,12Khashab M.A. Fujii L.L. Baron T.H. et al.EUS-guided biliary drainage for patients with malignant biliary obstruction with an indwelling duodenal stent (with videos).Gastrointest Endosc. 2012; 76: 209-213Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar, 13Henry W.A. Singh V.K. Kalloo A.N. et al.Simultaneous EUS-guided transbulbar pancreaticobiliary drainage (with video).Gastrointest Endosc. 2012; 76: 1065-1067Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar, 28Sharaiha R. Kalloo A.N. Khashab M.A. Endoscopic ultrasound-guided hepato-esophagostomy for transesophageal biliary drainage (with video).Gastrointest Endosc. 2012; 76: 227-228Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar but there is the risk of a bile leak if the biliary obstruction cannot be lessened. The use of several techniques may facilitate successful and safe TL stent placement. First, the TL tract should not be dilated until a satisfactory guidewire position has been achieved. Second, the tract should be dilated only to a diameter to allow stent insertion while avoiding aggressive dilation that risks a biliary leak.12Khashab M.A. Fujii L.L. Baron T.H. et al.EUS-guided biliary drainage for patients with malignant biliary obstruction with an indwelling duodenal stent (with videos).Gastrointest Endosc. 2012; 76: 209-213Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar Third, cautery-assisted tract dilation should be avoided if possible to minimize the risk of adverse events, particularly bleeding and bile leak. Fourth, fully covered metal stents should be used to minimize the risk of stent migration and bile leakage. Finally, carbon dioxide insufflation should be used to help reduce the risk of pneumoperitoneum. We agree with those who favor RV EUS-BD, but believe that a TL approach is an effective and safe alternative, provided the described safeguards are adopted. Artifon et al29Artifon E.L. Marson F.P. Gaidhane M. et al.Hepaticogastrostomy or choledochoduodenostomy for distal malignant biliary obstruction after failed ERCP: Is there any difference?.Gastrointest Endosc. 2015; 81: 950-959Abstract Full Text Full Text PDF PubMed Scopus (108) Google Scholar recently reported a randomized trial comparing the outcomes of EUS-CDS and EUS-HGS in 49 patients with unresectable distal malignant biliary obstruction after ERCP. The technical success rate was 91% for CDS and 96% for HGS (P = .61). Similarly, clinical success was comparable in both groups (77% vs 91%, respectively; P = .23). The mean procedural time (48.4 vs 47.8 minutes, P = .84), and the postprocedure mean quality-of-life scores were also similar. The overall adverse event rate was 16.3% (CDS, 12.5%; HGS, 20%). The authors concluded that CDS and HGS techniques provide similar efficacy and safety and both are valid options for draining distal malignant biliary obstruction after failed ERCP. The RV and TL techniques are both amenable to either an intrahepatic or an extrahepatic approach in patients with native anatomy. However, the optimal access route has not been established for either technique. In cases of RV EUS-BD, Dhir et al30Dhir V. Bhandari S. Bapat M. et al.Comparison of transhepatic and extrahepatic routes for EUS-guided rendezvous procedure for distal CBD obstruction.United European Gastroenterol J. 2013; 1: 103-108Crossref Scopus (56) Google Scholar found that the extrahepatic transduodenal approach was associated with significantly shorter procedure times and less postprocedure pain, bile leak, and subdiaphragmatic air. They also found a trend toward higher success rates with extrahepatic RV (93% vs 50%).25Park do H. Jeong S.U. Lee B.U. et al.Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video).Gastrointest Endosc. 2013; 78: 91-101Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar Similarly, limited data suggest that direct TL EUS-BD via an extrahepatic route (CDS) may be safer than the intrahepatic route (HGS).9Park D.H. Jang J.W. Lee S.S. et al.EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results.Gastrointest Endosc. 2011; 74: 1276-1284Abstract Full Text Full Text PDF PubMed Scopus (229) Google Scholar Therefore, many prefer extrahepatic access whether performing RV or direct TL EUS-BD. Dhir et al31Dhir V. Artifon E.L. Gupta K. et al.Multicenter study on endoscopic ultrasound-guided expandable biliary metal stent placement: choice of access route, direction of stent insertion, and drainage route.Dig Endosc. 2014; 26: 430-435Crossref PubMed Scopus (109) Google Scholar evaluated clinical success and adverse event rates in 68 patients undergoing EUS-BD by using a variety of techniques. The overall success rate was 95.6% and was similar regardless of the technique. Adverse events were reported in 14 patients (20.6%), with death occurring in 4 patients (4.4%). The adverse event rate was significantly higher for the intrahepatic access versus extrahepatic (transduodenal) route (30.5% vs 9.3%, P = .03). There was no significant difference in adverse event rates among TL and transpapillary approaches or direct versus RV techniques. Based on logistic regression analysis, transhepatic access was the only independent risk factor for adverse events (P = .03). As a result of the analogous technical and clinical success of EUS-BD regardless of access route, stent insertion direction, or drainage route and the association of intrahepatic access with adverse events, the authors recommended the extrahepatic (transduodenal) route for EUS-BD with RV stent placement whenever possible. Causal factors for the increased risk of intrahepatic access have not been definitely established, but likely relate to multiple reasons. First, the intrahepatic route necessitates that the needle traverse the peritoneal cavity, which risks pneumoperitoneum and peritoneal bile leakage. Second, the stomach and liver move independently (eg, during respiration and peristalsis), which may induce stent migration, biloma formation, and increased trauma to the bilioenteric tract (which increases the risk of postprocedure pain and bile leak). Finally, smaller-caliber intrahepatic ducts may not accommodate wider 8- to 10-mm metal stents, which can theoretically predispose to pneumoperitoneum and bile leakage due to incomplete sealing of the bilioenteric fistula. Extrahepatic access, on the other hand, has many potential advantages including the close proximity of the duodenum to the dilated bile duct and a relatively fixed bile duct with minimal respiratory influence. Further prospective studies comparing the safety of these different techniques are needed. ERCP in patients with GOO is challenging, especially in the presence of a duodenal SEMS. Although ERCP can be accomplished by fenestration of the stent in certain cases, other approaches for biliary access and drainage are needed when the papilla cannot be reached or visualized.12Khashab M.A. Fujii L.L. Baron T.H. et al.EUS-guided biliary drainage for patients with malignant biliary obstruction with an indwelling duodenal stent (with videos).Gastrointest Endosc. 2012; 76: 209-213Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar Khashab et al12Khashab M.A. Fujii L.L. Baron T.H. et al.EUS-guided biliary drainage for patients with malignant biliary obstruction with an indwelling duodenal stent (with videos).Gastrointest Endosc. 2012; 76: 209-213Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar performed EUS-BD in 9 patients with pre-existing duodenal SEMSs and an inaccessible ampulla. The bile duct was accessed via either a transgastric (n = 3) or transduodenal (n = 6) approach, requiring needle passage through the interstices of the duodenal stent in 5 patients. Biliary access was accomplished via an extrahepatic (n = 7) or an intrahepatic approach (n = 2). After guidewire passage and tract dilation, fully covered or uncovered SEMSs were placed. Antegrade stent insertion (direct TL access) was required in 2 patients due to failed efforts to advance the guidewire antegrade through the obstruction and to the duodenum, thereby prohibiting transpapillary drainage. Jaundice resolved in all patients, and no significant adverse events were reported. Mild pancreatitis and cholecystitis developed in 1 patient after placement of a fully covered transpapillary SEMS.12Khashab M.A. Fujii L.L. Baron T.H. et al.EUS-guided biliary drainage for patients with malignant biliary obstruction with an indwelling duodenal stent (with videos).Gastrointest Endosc. 2012; 76: 209-213Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar Hamada et al32Hamada T. Isayama H. Nakai Y. et al.Transmural biliary drainage can be an alternative to transpapillary drainage in patients with an indwelling duodenal stent.Dig Dis Sci. 2014; 59: 1931-1938Crossref PubMed Scopus (57) Google Scholar compared the safety and efficacy of EUS-BD (n = 7) and ERCP-directed transpapillary drainage (n = 13) in patients with an indwelling duodenal SEMS. EUS-BD was performed via HGS by using an SEMS in 3 patients and via CDS by using an SEMS or a plastic stent in 2 patients each. Transpapillary drainage was performed by using an SEMS in all patients. The stent patency rate in the EUS-BD group was higher than that in the transpapillary drainage group at 1 month (100% vs 71%) and 3 months (83% vs 29%). The EUS-BD group had a nonsignificantly lower rate of stent dysfunction compared with the transpapillary group (14% vs 54%, P = .16). The adverse event rate was similar between the groups (P = 1.00), with moderate bleeding in 1 patient in the EUS-BD group and mild pancreatitis in 1 patient in the transpapillary group. The authors concluded that EUS-BD is a viable alternative to transpapillary drainage in the presence of an indwelling duodenal SEMS. We favor EUS-BD over ERCP in patients with duodenal stents due to the potential for improved stent patency, especially when considering the challenges of retrograde cannulation in these patients.33Khashab M.A. Valeshabad A.K. Leung W. et al.Multicenter experience with performance of ERCP in patients with an indwelling duodenal stent.Endoscopy. 2014; 46: 252-255Crossref PubMed Scopus (30) Google Scholar The presence of an isolated right intrahepatic ductal obstruction is largely viewed as a contraindication to EUS-BD. Park et al34Park S.J. Choi J.H. Park do H. et al.Expanding indication: EUS-guided hepaticoduodenostomy for isolated right intrahepatic duct obstruction (with video).Gastrointest Endosc. 2013; 78: 374-380Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar evaluated the feasibility and safety of EUS-guided hepatoduodenostomy in patients with isolated right intrahepatic ductal obstruction. EUS-cholangiography of the right intrahepatic ductal was successful in 6 patients, with antegrade stenting achieved in 2 patients, antegrade transanastomotic stenting in 1 patient, antegrade transanastomotic balloon dilation in 1 patient, and cholangiography alone as a roadmap in 1 patient. The procedure was unsuccessful in 1 patient because of failed guidewire manipulation. The technical success rate of EUS-guided hepatoduodenostomy–assisted cholangiography and biliary decompression was 100% (6 of 6) and 83% (5 of 6), respectively. There were no procedure-related adverse events. Additional studies are needed to verify these promising preliminary findings. Data directly comparing EUS-BD with PTBD are limited, leaving uncertainty about how best to manage patients after failed ERCP. There has been only 1 small randomized, controlled trial that included 25 patients with malignant biliary obstruction and failed ERCP with similar outcomes reported in both arms (see previously).24Artifon E.L. Aparicio D. Paione J.B. et al.Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage.J Clin Gastroenterol. 2012; 46 (768-4)Crossref PubMed Scopus (166) Google Scholar More recently, Khashab et al35Khashab M.A. Valeshabad A.K. Afghani E. et al.A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP.Dig Dis Sci. 2015; 60: 557-565Crossref PubMed Scopus (153) Google Scholar retrospectively compared the outcomes of 73 patients who underwent either EUS-BD (n = 22) or PTBD (n = 51). Although the technical success rate was higher for PTBD (100% vs 86.4%, P = .007), the clinical success rate was similar (92.2% vs 86.4%, P = .40). PTBD was associated with a higher risk of adverse events (index procedure: 39.2% vs 18.2%; all procedures including reinterventions: 80.4% vs 15.7%), but the stent patency and survival were similar for both groups. The total cost was more than 2 times higher for the PTBD procedure (P = .004), mainly the result of the significantly greater need for reintervention (80.4% vs 15.7%, P = .001). The authors concluded that EUS-BD and PTBD appear to provide comparable efficacy, but EUS-BD may offer more safety at a significantly lower cost due to the need for fewer reinterventions. A potential advantage of EUS-BD is the ability to access various sites of the biliary system,31Dhir V. Artifon E.L. Gupta K. et al.Multicenter study on endoscopic ultrasound-guided expandable biliary metal stent placement: choice of access route, direction of stent insertion, and drainage route.Dig Endosc. 2014; 26: 430-435Crossref PubMed Scopus (109) Google Scholar thereby allowing drainage even in the setting of duodenal obstruction or duodenal bypass surgeries. EUS-BD may also be performed in patients with ascites and liver metastasis that may be difficult when using percutaneous approaches. In addition, the avoidance of percutaneous catheters eliminates the associated skin irritation, leakage, and pain that are particularly troublesome to patients. Moreover, EUS-BD can be performed during the same endoscopy session after failed ERCP, which avoids the need for repeated interventions and allows for timely biliary drainage and initiation or resumption of chemoradiation if needed.15Shah J.N. Marson F. Weilert F. et al.Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla.Gastrointest Endosc. 2012; 75: 56-64Abstract Full Text Full Text PDF PubMed Scopus (179) Google Scholar, 25Park do H. Jeong S.U. Lee B.U. et al.Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video).Gastrointest Endosc. 2013; 78: 91-101Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar Additional study is needed to evaluate these theoretical advantages of EUS-BD. Hara et al36Hara K. Yamao K. Hijioka S. et al.Prospective clinical study of endoscopic ultrasound-guided choledochoduodenostomy with direct metallic stent placement using a forward-viewing echoendoscope.Endoscopy. 2013; 45: 392-396Crossref PubMed Scopus (97) Google Scholar performed a prospective study of EUS-CDS for primary therapy of malignant biliary obstruction (ie, not after failed ERCP) in 17 patients. Both technical and clinical success was achieved in 94% of patients. However, we believe that, based on published data and personal experience, currently EUS-BD should be reserved as a rescue technique. We recommend obtaining informed consent from all patients for possible EUS-BD at the time of ERCP, in particular those at high risk of failed biliary cannulation (eg, surgical anatomy, previous failed ERCP, periampullary cancer with duodenal invasion on imaging, duodenal stent covering the ampulla). This consent process mandates a thorough discussion regarding the potential indications, benefits, and risks after possible failed cannulation and available alternatives such as repeat ERCP versus percutaneous or surgical drainage. It also requires that the endoscopist ensures adequate time, skilled staff, and appropriate backup in the event of failed EUS-BD and/or resulting adverse event. Nevertheless, consenting for EUS-BD at the time of ERCP precludes the need for repeated endoscopic interventions and allows for timely biliary drainage. The growth in acceptance and performance of EUS-BD has been slowed, not only by the relative lack of well-designed studies and data, but also by the limitations in echoendoscope design. Current echoendoscopes have an elongated and relatively wide diameter tip that may preclude traversal of luminal stenosis. Also, once guidewire access is obtained, the echoendoscope design limits adequate endoscopic visualization that makes stent deployment and other endotherapy challenging. A forward-view echoendoscope has been developed that may overcome this technical challenge. This new device has a blunt tip, similar to a standard gastroscope, and preliminary data for performing interventions appear promising.37Voermans R.P. Ponchon T. Schumacher B. et al.Forward-viewing versus oblique-viewing echoendoscopes in transluminal drainage of pancreatic fluid collections: a multicenter, randomized, controlled trial.Gastrointest Endosc. 2011; 74: 1285-1293Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar However, use of the forward-viewing echoendoscope has been limited, with many endosonographers unsure as to its role or greater utility. Another hindrance to the progress of therapeutic EUS in general is the absence of dedicated and procedure/technology-specific accessories. Currently, most EUS-guided interventions are being performed by using ERCP accessories, some of which are not conducive for use with a curvilinear echoendoscope. A novel lumen-apposing metal stent (Axios; Xlumena, Mountain View, Calif) was recently developed and has been successfully tested in experimental38Binmoeller K.F. Shah J. A novel lumen-apposing stent for transluminal drainage of nonadherent extraintestinal fluid collections.Endoscopy. 2011; 43: 337-342Crossref PubMed Scopus (154) Google Scholar and clinical39Itoi T. Binmoeller K.F. Shah J. et al.Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos).Gastrointest Endosc. 2012; 75: 870-876Abstract Full Text Full Text PDF PubMed Scopus (345) Google Scholar, 40de la Serna-Higuera C. Perez-Miranda M. Gil-Simon P. et al.EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent.Gastrointest Endosc. 2013; 77: 303-308Abstract Full Text Full Text PDF PubMed Scopus (108) Google Scholar settings. The Axios is a fully covered, saddle-shaped, 6 to 8 mm in diameter nitinol stent with bilateral anchor flanges for CDS (Fig. 5). The design helps appose tissues, thereby minimizing the risk of leak and promoting fistula formation between nonadherent extraintestinal fluid collections or the bile duct and the GI lumen. Preliminary data for this novel stent design for gallbladder drainage are promising,39Itoi T. Binmoeller K.F. Shah J. et al.Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos).Gastrointest Endosc. 2012; 75: 870-876Abstract Full Text Full Text PDF PubMed Scopus (345) Google Scholar, 40de la Serna-Higuera C. Perez-Miranda M. Gil-Simon P. et al.EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent.Gastrointest Endosc. 2013; 77: 303-308Abstract Full Text Full Text PDF PubMed Scopus (108) Google Scholar and our limited personal experience also suggests its safe use for extrahepatic bile duct drainage. Its use for drainage of intrahepatic biliary ducts may be relatively contraindicated at this time due to its short length and wide diameter. Existing data suggest that EUS-BD is a safe and effective procedure to provide biliary access and drainage after failed ERCP whether it is performed via a RV or direct TL technique. An extrahepatic access route may be preferable for distal biliary obstruction and appears to be associated with a decreased incidence of adverse events. EUS-BD provides a viable alternative to PTBD, and limited available data suggest equivalent efficacy and safety. Indications and methods for EUS-BD are yet to be standardized; thus, the approach should be individualized for each patient based on the endoscopist's experience and the patient’s anatomy. Further prospective, multicenter, controlled studies are needed to further delineate appropriate indications, predictors of success and adverse events, optimal approach, and clinical outcomes compared with other drainage procedures.
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