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Do the benefits of metal stents justify the costs? A systematic review and meta-analysis of trials comparing endoscopic stents for malignant biliary obstruction.
Are we meeting the standards set for endoscopy? Results of a large-scale prospective survey of endoscopic retrograde cholangio-pancreatograph practice.
Nevertheless, a pre-existing gastroduodenal stent (GDS) poses significant technical challenges for the endoscopist. The stent can be narrow and occluded as a result of tissue or tumor ingrowth, the stent interstices can make it difficult to pass a sphincterotome, and the stent can completely obscure the papilla, thereby preventing biliary access. In such cases, percutaneous transhepatic biliary drainage (PTBD) has traditionally been the mainstay of therapy. However, PTBD is associated with significant adverse events, re-intervention rates, and cost.
A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP.
Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis.
In comparison with PTBD, EUS-BD is associated with (1) minimal postprocedure pain, (2) drainage routes for both intrahepatic and extrahepatic bile ducts, (3) fewer re-interventions, (4) better cosmesis because of the lack of external drainage catheters, (5) lower adverse event rates, (6) ability to perform the procedure during the same session as the failed ERCP, and (7) shorter hospital stay.
Staub J, Siddiqui A, Taylor LJ, et al. ERCP performed through previously placed duodenal stents: a multicenter retrospective study of outcomes and adverse events. Gastrointest Endosc. Epub 2018 Feb 6.
More recently, retrospective studies have reported feasibility and excellent procedural outcomes of EUS-BD in patients with malignant biliary obstruction and pre-existing duodenal stents.
A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP.
Multicenter comparative evaluation of endoscopic placement of expandable metal stents for malignant distal common bile duct obstruction by ERCP or EUS-guided approach.
Outcomes of endoscopic biliary drainage in pancreatic cancer patients with an indwelling gastroduodenal stent: a multicenter cohort study in West Japan.
compared the outcomes of endoscopic transpapillary stent placement (ETS) by means of ERCP and primary EUS-BD (without prior failed ERCP) in patients with unresectable pancreatic cancer and indwelling GDS across 5 tertiary centers in Japan over a 5-year period. The authors endeavored to reduce heterogeneity in the cohort by stratifying patients into 3 subgroups: (1) uncovered GDS overlying the papilla, (2) covered GDS overlying the papilla, and (3) GDS not overlying the papilla. The EUS-BD group underwent transmural drainage by means of choledochoduodenostomy (CDS), hepaticogastrostomy (HGS), or gallbladder drainage (GBD) (as a last resort). Cautery was not used in any of the patients undergoing EUS-BD. Of the 39 patients in the study, 59% had a GDS overlying the papilla. The majority (30/39) underwent initial biliary drainage, and 9 patients underwent re-intervention for recurrent biliary obstruction that had been previously treated with the insertion of biliary stents before GDS placement. Among the 39 included patients, ETS was performed in 25 patients and EUS-BD in 14 patients. Technical success was almost double in the EUS-BD group in comparison with the ETS group (95.2% vs 56%, P < .01), as was the clinical success rate (90.5% vs 52%, P = .01). However, in patients with pre-existing biliary stents, ETS was successful in the majority (83%) of cases. EUS-BD was successful in most patients (86%) in whom an initial attempt at ERCP had failed. Importantly, the authors did not find a statistically significant difference in adverse event rates between the ETS and EUS-BD groups (32% vs 42.9%, P = .23). It is worth mentioning that the rates of adverse events in both study arms were noticeably higher than expected and reported in relevant literature.
More than 50% of the adverse events in the current study were cholangitis, recurrent jaundice, or both. Cholangitis typically ensues in technically difficult procedures or whenever complete biliary drainage is not achieved. Short-term recurrent jaundice in this patient population is not surprising and could have been due to known gastric outlet obstruction and resulting enterobiliary reflux.
Another noteworthy finding in the study was the insignificant difference in stent patency rates and time to stent dysfunction between both groups. When EUS-BD with transmural drainage is performed, the stent does not traverse the stricture. This theoretically reduces the risk of tumor ingrowth and stent obstruction in comparison with transpapillary stents.
Multicenter comparative evaluation of endoscopic placement of expandable metal stents for malignant distal common bile duct obstruction by ERCP or EUS-guided approach.
These results were not replicated in the current study, possibly because of pre-existing duodenal stents and gastric outlet obstruction, resulting in reflux of duodenal contents into the biliary stents, particularly if the biliary stent and GDS overlap.
Comparison of the clinical impact of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for bile duct obstruction with duodenal obstruction.
reported significantly higher rates of cholangitis and lower stent patency rates in patients with GDS and CDS compared with GDS and HGS.
Although the study is limited by its retrospective design, small sample size, and heterogeneous study population and interventions, the results suggest that in patients with indwelling GDS and biliary obstruction, adopting an algorithmic approach may help maximize the success rates of biliary drainage (Fig. 1). We suggest an initial attempt at ERCP in patients with GDSs not covering the papilla and in those with pre-existing biliary stents (even if the GDS covers the papilla). EUS-BD could then be performed in case of failed ERCP. In patients without prior biliary stents where the GDS obscures the papilla, primary EUS-BD could be attempted at centers with expertise in interventional EUS. Furthermore, HGS should be attempted over CDS when possible, given the likely lower rates of recurrent biliary obstruction and cholangitis in this patient cohort. In short, patients with in situ GDSs requiring biliary drainage should give up-front consent for both ERCP and EUS-BD. This avoids the need for repeated procedures with their associated cost and negative impact on patients’ quality of life.
Figure 1Suggested algorithm for approach to biliary drainage in patients with malignant duodenal and biliary obstruction with pre-existing gastroduodenal stents. CDS, choledochoduodenostomy; EUS-BD, EUS-guided biliary drainage; GDS, gastroduodenal stent; HGS, hepatogastrostomy.
However, at present, the availability of EUS-BD remains limited to a few expert centers worldwide. Mastery of the entire range of EUS-BD techniques (CDS, HGS, rendezvous, antegrade transpapillary stent placement) is important to be able to provide service to patients with both proximal and distal malignant biliary obstruction and various anatomic variations. The safety of the procedure is also tied in with the endoscopist’s experience and learning curve. Wide adoption of EUS-BD is partly restricted because of inadequate access to training facilities; the use of ex-vivo models may be of interest and benefit.
Novel ex vivo model for hands-on teaching of and training in EUS-guided biliary drainage: creation of "Mumbai EUS" stereolithography/3D printing bile duct prototype (with videos).
Most importantly, despite nearly 2 decades of experience in this technique, there remains a dearth of dedicated EUS-BD devices. A new EUS-guided CDS, a fully covered lumen-apposing metal stent loaded onto a 1-step hot delivery system (Axios, Boston Scientific, Natick, Mass), has recently become available; however, the device is suitable only for CDS and recommended for drainage of obstructed bile ducts with a minimum diameter of 14 mm. Another 1-step dedicated device (DEUS, Standard Sci Tech, Inc, Seoul, South Korea) consists of a 6-mm to 8-mm partially covered metal stent preloaded onto a catheter with a 7F outer sheath and a 3F smooth tapered metal tip. These characteristics enable easy and efficient over-the-wire fistula puncture, tract dilation, and stent deployment.
The slender design of the device allows delivery of the stent into bile ducts with smaller diameters. A prospective randomized trial involving this device demonstrated a low adverse event rate (8.8%), with all episodes graded as mild.
Further studies with dedicated devices are needed to assess improvement of procedure efficacy, efficiency, and safety.
ERCP fails in the majority of patients with GDS when the stent covers the ampulla. EUS-BD plays a major role in such patients. It is, however, disappointing that EUS-BD remains limited to few expert institutions around the world. We hope that the recently available tailored and dedicated accessories will help further disseminate this elegant procedure worldwide. Continued device innovation and refinement of current tools are needed to render EUS-BD a mainstream procedure.
Disclosure
Dr Saxena is a consultant for Boston Scientific. Dr Khashab is a consultant for Boston Scientific, Olympus, and Medtronic and is on the medical advisory board for Boston Scientific and Olympus.
References
Baron T.H.
Expandable metal stents for the treatment of cancerous obstruction of the gastrointestinal tract.
Do the benefits of metal stents justify the costs? A systematic review and meta-analysis of trials comparing endoscopic stents for malignant biliary obstruction.
Are we meeting the standards set for endoscopy? Results of a large-scale prospective survey of endoscopic retrograde cholangio-pancreatograph practice.
A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP.
Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis.
Staub J, Siddiqui A, Taylor LJ, et al. ERCP performed through previously placed duodenal stents: a multicenter retrospective study of outcomes and adverse events. Gastrointest Endosc. Epub 2018 Feb 6.
Multicenter comparative evaluation of endoscopic placement of expandable metal stents for malignant distal common bile duct obstruction by ERCP or EUS-guided approach.
Outcomes of endoscopic biliary drainage in pancreatic cancer patients with an indwelling gastroduodenal stent: a multicenter cohort study in West Japan.
Comparison of the clinical impact of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for bile duct obstruction with duodenal obstruction.
Novel ex vivo model for hands-on teaching of and training in EUS-guided biliary drainage: creation of "Mumbai EUS" stereolithography/3D printing bile duct prototype (with videos).
Gastroduodenal and biliary obstruction may occur synchronously or asynchronously in advanced pancreatic cancer, and endoscopic double stent placement may be required. EUS-guided biliary drainage (EUS-BD) often is performed after unsuccessful placement of an endoscopic transpapillary stent (ETS), and EUS-BD may be beneficial in double stent placement. This retrospective multicenter cohort study compared the outcomes of ETS placement and EUS-BD in patients with an indwelling gastroduodenal stent (GDS).
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