EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results.

EUS-guided biliary drainage (EUS-BD) has been proposed as an effective alternative for percutaneous transhepatic biliary drainage (PTBD) after failed ERCP. To date, the risk factors for adverse events and long-term outcomes of EUS-BD with transluminal stenting (EUS-BDS) have not been fully explored. To evaluate risk factors for adverse events and long-term outcomes of EUS-BDS. Prospective follow-up study. Tertiary-care academic center. This study involved 57 consecutive patients with malignant or benign biliary obstruction undergoing EUS-BDS after failed ERCP. EUS-guided hepaticogastrostomy (EUS-HGS) and EUS-guided choledochoduodenostomy with transluminal stenting (EUS-CDS). Risk factors for postprocedure and late adverse events and clinical outcomes of EUS-BDS. The overall technical and functional success rates, respectively, in the EUS-BDS group were 96.5% (intention-to-treat, n = 55/57) and 89% (per-protocol, n = 49/55). Postprocedure adverse events developed after EUS-BDS in 11 patients (20%, n = 11/55). This included bile peritonitis (n = 2), mild bleeding (n = 2), and self-limited pneumoperitoneum (n = 7). In multivariate analysis, needle-knife use was the single risk factor for postprocedure adverse events after EUS-BDS (odds ratio 12.4; P = .01). A late adverse event in EUS-BDS was distal stent migration (7%, n = 4/55). The mean stent patencies with EUS-HGS and EUS-CDS were 132 days and 152 days, respectively. Single-operator performed, nonrandomized study. EUS-HGS and EUS-CDS may be relatively safe and can be used as an alternative to PTBD after failed ERCP. Both techniques offer durable and comparable stent patency. The use of a needle-knife for fistula dilation in EUS-BDS should be avoided if possible.

Park DH ，Jang JW ，Lee SS ，Seo DW ，Lee SK ，Kim MH ... -  《-》

Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video).

EUS-guided biliary drainage (EUS-BD) was introduced as an effective alternative to percutaneous transhepatic biliary drainage after failed ERCP. However, EUS-BD is technically challenging. The intraductal manipulation of the guidewire seems to be the most difficult stage of the procedure. Therefore, technical advances in guidewire manipulation may be required for EUS-BD. To evaluate our treatment algorithm for guidewire manipulation protocol for EUS-BD after failed ERCP. Prospective, observational cohort study. A tertiary-care academic center. Forty-five consecutive patients undergoing EUS-BD failed ERCP. Enhanced guidewire manipulation protocol (with a plane parallel to the long axis of the bile duct with an EUS needle tip or a new 0.025-inch guidewire in an extrahepatic approach and intrahepatic bile duct puncture of segment 2 and 4F cannula with guidewire probing in the intrahepatic approach) for rendezvous and antegrade therapy, EUS-BD with transluminal stenting for duodenal invasion, and crossover to another technique if each technique failed. Technical and functional success rates and adverse event rate of the current treatment algorithm for EUS-BD. The overall technical and functional success rates of EUS-BD in this study were 91% (intention to treat, n = 41/45) and 95% (per protocol, n = 39/41), respectively. Specifically, rendezvous (n = 20) and antegrade therapy (n = 14) were initially feasible in 34 of 45 patients (76%). With our protocol, 25 of 45 patients (56%) were eventually treated with rendezvous and antegrade therapy as a first-line or crossover treatment. EUS-guided biliary drainage with transluminal stenting in patients with duodenal invasion or failed antegrade therapy was feasible in the remaining 20 patients (44%). The overall adverse event rate of EUS-BD was 11%. Single-operator, nonrandomized study. In this prospective study, our treatment algorithm with an enhanced guidewire manipulation protocol appeared to be technically feasible and effective. Given the favorable success rate and acceptable adverse event rate, this may be considered the standard treatment algorithm for future randomized trials of EUS-BD and percutaneous transhepatic biliary drainage.

Park DH ，Jeong SU ，Lee BU ，Lee SS ，Seo DW ，Lee SK ，Kim MH ... -  《-》

Preliminary report on a new hybrid metal stent for EUS-guided biliary drainage (with videos).

EUS-guided biliary drainage (EUS-BD) may be a feasible and useful alternative in patients with malignant biliary obstruction after failed ERCP. One of the main limitations of EUS-BD is the lack of devices specifically tailored to this technique. To evaluate a newly developed hybrid metal stent customized for EUS-BD. A prospective, observational study. A tertiary academic referral center. A total of 27 consecutive patients with malignant biliary obstruction who were candidates for alternative techniques for biliary drainage because of failed ERCP were enrolled. EUS-BD with a newly developed hybrid metal stent. The technical and clinical success rates and adverse events, including proximal or distal stent migration and cholangitis. EUS-guided hepaticogastrostomy was performed in 10 patients, and EUS-guided choledochoduodenostomy was performed in 17 patients. The technical success rate of EUS-BD with the hybrid metal stent was 100% (27/27), and clinical success was achieved in 96.3% (26/27) of the cases. Adverse events developed in 5 patients (5/27, 18.5%), including a self-limited pneumoperitoneum in 3 patients, minor bleeding in 1 patient, and abdominal pain in 1 patient. During the follow-up period (median 134 days), proximal or distal stent migration was not observed. This study was performed at a single center by a single experienced operator with a relatively small number of patients. EUS-BD with a hybrid metal stent is technically feasible and can be an effective treatment for malignant biliary obstruction after failed ERCP. Hybrid metal stents may be used safely in EUS-BD, and they can prevent stent-related adverse events.

Song TJ ，Lee SS ，Park DH ，Seo DW ，Lee SK ，Kim MH ... -  《-》

Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial.

In patients with malignant distal bile duct obstruction and normal gastrointestinal anatomy, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is indicated when endoscopic retrograde cholangiopancreatography (ERCP) fails. The ERCP drainage route passes through the tumor, whereas the EUS-CDS route does not. Therefore, EUS-CDS is expected to have a longer stent patency than ERCP. However, for first-line biliary drainage, it remains unclear whether EUS-CDS or ERCP is superior in terms of stent patency. To reduce the frequency of highly adverse events (AEs) such as bile peritonitis or stent migration following EUS-CDS, we developed an antimigration metal stent with a thin delivery system for tract dilatation. This study is designed to assess whether EUS-CDS with this novel stent is superior to ERCP with a traditional metal stent in terms of stent patency when the two techniques are used for first-line drainage of malignant distal biliary obstruction. This study is a multicenter single-blinded randomized controlled trial (RCT) involving 95 patients in four tertiary centers. Patients with malignant distal biliary obstruction that is unresectable or presents a very high surgical risk and who pass the inclusion and exclusion criteria will be randomized to EUS-CDS or ERCP in a 1:1 proportion. The primary endpoint is the stent patency rate 180 days after stent insertion. Secondary outcomes include the rates of technical success, clinical success, technical success in cases not requiring fistulous-tract dilation (only EUS-CDS group), procedure-related AEs, re-intervention success, patients receiving post-drainage chemotherapy, procedure time, and overall survival time. If EUS-CDS is superior to ERCP in terms of stent patency and safety for the first-line drainage of malignant distal biliary obstruction, it is expected that the first-line drainage method will be changed from ERCP to EUS-CDS, and that interruption of chemotherapy due to stent dysfunction can be avoided. University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), ID: UMIN000041343. Registered on August 6, 2020. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047201Version number: 1.2, December 7, 2020.

Itonaga M ，Kitano M ，Yoshikawa T ，Ashida R ，Yamashita Y ，Hatamaru K ，Takenaka M ，Yamazaki T ，Ogura T ，Nishioka N ，Sakai A ，Masuda A ，Shiomi H ，Shimokawa T ... -  《-》

Long-term outcomes of a newly developed hybrid metal stent for EUS-guided biliary drainage (with videos).

Although fully covered self-expandable metal stents (FCSEMSs) have been commonly used for EUS-guided biliary drainage (EUS-BD), FCSEMS migration is a main limitation of this procedure. In the present study we evaluated the technical and clinical success rates, adverse events, and long-term outcomes of a newly developed hybrid stent that has been customized for EUS-BD. From September 2011 to May 2015, 54 consecutive patients with biliary obstruction were enrolled in this prospective, observational study. These patients were candidates for alternative BD techniques because of failed ERCP. The hybrid metal stent used for EUS-BD in this study was partially covered, had anchoring flaps, and is commercially available in Korea. EUS-guided hepaticogastrostomy (EUS-HGS) was performed in 21 patients and EUS-guided choledochoduodenostomy (EUS-CDS) in 33 patients. The technical and clinical success rates of EUS-BD were 100% (54/54) and 94.4% (51/54), respectively. Immediate adverse events developed after EUS-BD in 9 patients (16.6%; cholangitis in 3, bleeding in 2, self-limited pneumoperitoneum in 3, and abdominal pain in 1). Proximal or distal stent migration was not observed during the follow-up period (median, 148.5 days; IQR, 79.7-244), and the mean stent patency duration was 166.3 days and 329.1 days in the EUS-HGS and EUS-CDS groups, respectively. EUS-BD with the hybrid metal stent is technically feasible and can effectively treat biliary obstruction after failed ERCP. EUS-BD with the hybrid metal stent can reduce stent-related adverse events, especially stent migration.

Cho DH ，Lee SS ，Oh D ，Song TJ ，Park DH ，Seo DW ，Lee SK ，Kim MH ... -  《-》