Clinical utility of treatment method conversion during single-session endoscopic ultrasound-guided biliary drainage.

Although several techniques for endoscopic ultrasound-guided biliary drainage (EUS-BD) are available at present, an optimal treatment algorithm of EUS-BD has not yet been established. To evaluate the clinical utility of treatment method conversion during single endoscopic sessions for difficult cases in initially planned EUS-BD. This was a single-center retrospective analysis using a prospectively accumulated database. Patients with biliary obstruction undergoing EUS-BD between May 2008 and April 2016 were included. The primary outcome was to evaluate the improvement in EUS-BD success rates by converting the treatment methods during a single endoscopic session. Secondary outcomes were clarification of the factors leading to the conversion from the initial EUS-BD and the assessment of efficacy and safety of the conversion as judged by technical success, clinical success, and adverse events (AEs). A total of 208 patients underwent EUS-BD during the study period. For 18.8% (39/208) of the patients, the treatment methods were converted to another EUS-BD technique from the initial plan. Biliary obstruction was caused by pancreatobiliary malignancies, other malignant lesions, biliary stones, and other benign lesions in 22, 11, 4, and 2 patients, respectively. The reasons for the difficulty with the initial EUS-BD were classified into the following 3 procedures: Target puncture (n = 13), guidewire manipulation (n = 18), and puncture tract dilation (n = 8). Technical success was achieved in 97.4% (38/39) of the cases and clinical success was achieved in 89.5% of patients (34/38). AEs occurred in 10.3% of patients, including bile leakage (n = 2), bleeding (n = 1), and cholecystitis (n = 1). The puncture target and drainage technique were altered in subsequent EUS-BD procedures in 25 and 14 patients, respectively. The final technical success rate with 95%CI for all 208 cases was 97.1% (95%CI: 93.8%-98.9%), while that of the initially planned EUS-BD was 78.8% (95%CI: 72.6%-84.2%). Among multi-step procedures in EUS-BD, guidewire manipulation appeared to be the most technically challenging. When initially planned EUS-BD is technically difficult, treatment method conversion in a single endoscopic session may result in successful EUS-BD without leading to severe AEs.

Minaga K ，Takenaka M ，Yamao K ，Kamata K ，Omoto S ，Nakai A ，Yamazaki T ，Okamoto A ，Ishikawa R ，Yoshikawa T ，Chiba Y ，Watanabe T ，Kudo M ... -  《-》

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 ... -  《-》

Multicenter retrospective study of endoscopic ultrasound-guided biliary drainage for malignant biliary obstruction in Japan.

Endoscopic ultrasound-guided biliary drainage (EUS-BD) is considered to be an effective salvage procedure for failed endoscopic retrograde cholangiopancreatography in patients with unresectable malignant biliary obstruction. The aim of this retrospective study was to evaluate the efficacy and feasibility of EUS-BD. From November 2006 to May 2012, a total of 64 patients who underwent EUS-BD (44 EUS-guided choledochoduodenostomy [EUS-CDS] and 20 EUS-guided hepaticogastrostomy [EUS-HGS]) at seven tertiary-care referral centers in Japan were included. The primary outcome was the technical success rate, and the secondary outcomes were the incidence of complications, stent dysfunction rate, time to stent dysfunction, and overall survival. The technical success rate for both EUS-CDS and EUS-HGS was 95%. The reasons for technical failure were two failed dilations of the anastomosis in EUS-CDS and one puncture failure in EUS-HGS. The stent dysfunction rate and 3-month dysfunction-free patency rate were 21% and 80% for EUS-CDS and 32% and 51% for EUS-HGS. There were 12 (six in EUS-CDS and six in EUS-HGS) procedure-related complications (19%): five cases of bile leakage (3/2), three stent misplacements (1/2), one pneumoperitoneum (1/0), two cases of bleeding (1/1), one perforation (1/0), and one biloma (0/1). Bile leakage was more frequently observed in patients who underwent plastic stent placement (11%) than in those with covered metal stents (4%). This Japanese multicenter study revealed a high success rate in EUS-BD. However, the complication rate was as high as that in previous series. Covered metal stents may be useful to reduce bile leakage in EUS-BD.

Kawakubo K ，Isayama H ，Kato H ，Itoi T ，Kawakami H ，Hanada K ，Ishiwatari H ，Yasuda I ，Kawamoto H ，Itokawa F ，Kuwatani M ，Iiboshi T ，Hayashi T ，Doi S ，Nakai Y ... -  《-》

EUS-guided biliary interventions for benign diseases and unsuccessful ERCP - a prospective unicenter feasibility study on a large consecutive patient cohort.

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for the treatment of biliary obstruction of any etiology. However, cannulation failure of the common bile duct (CBD) by ERCP occurs in 5-10%. Alternatives after a failed ERCP are re-ERCP by an expert endoscopist, percutaneous transhepatic cholangio drainage (PTCD), (balloon) enteroscopy-assisted ERCP, or surgery. Endoscopic ultrasonography-guided drainage of the bile ducts (EUS-BD) is becoming the standard of care in tertiary referral centers for cases of failed ERCP in patients with malignant obstruction of the CBD. In expert hands, EUS-guided biliary drainage has excellent technical/clinical success rates and lower complication rates compared to PTCD. Despite the successful performance of EUS-BD in malignant cases, its use in benign cases is limited. The aim of this study (design, systematic prospective clinical observational study on quality assurance in daily clinical practice) was to evaluate the efficacy and safety of EUS-BD in benign indications. Patients with cholestasis and failed ERCP were recruited from a prospective EUS-BD registry (2004-2020). One hundred and three patients with EUS-BD and benign cholestasis were extracted from the registry (nTotal = 474). Indications of EUS-BDs included surgically altered anatomy (n = 65), atypical bile duct percutaneous transhepatic cholangio orifice at the duodenal junction from the longitudinal to the horizontal segment (n = 1), papilla of Vater not reached due to the gastric outlet/duodenal stenoses (n = 6), papilla that cannot be catheterized (n = 24), and proximal bile duct stenosis (n = 7). The primary endpoint was technical and clinical success. Secondary endpoints were procedure-related complications during the hospital stay. 103 patients with EUS-BD and benign cholestasis were extracted from the registry (nTotal=474). Different transluminal access routes were used to reach the bile ducts: transgastric (n = 72/103); -duodenal (n = 16/103); -jejunal (n = 14/103); combined -duodenal and -gastric (n = 1/103). The technical success rate was 96 % (n = 99) for cholangiography. Drainage was not required in 2 patients; balloon dilatation including stone extraction was sufficient in 17 cases (16.5 %; no additional or prophylactic insertion of a drain). Transluminal drainage was achieved in n = 68/103 (66 %; even higher in patients with drain indication only) by placement of a plastic stent (n = 29), conventional biliary metal stents (n = 24), HotAXIOS stents (n = 5; Boston Scientific, Ratingen, Germany), Hanaro stents (n = 6; Olympus, Hamburg, Germany), HotAXIOS stents and plastic stents (n = 1), HotAXIOS stents and metal stents (n = 1) and metal stents and plastic stents (n = 2). Techniques for stone extraction alone (nSuccessful=17) or stent insertion (nTotal = 85; nSuccessful=85 - rate, 100 %) and final EUS-BD access pathway included: Rendezvous technique (n = 14/85; 16.5 %), antegrade internal drainage (n = 20/85; 23.5 %), choledochointestinostomy (n = 7/85; 8.2 %), antegrade internal and hepaticointestinostomy (n = 22/85; 25.9 %), hepaticointestinostomy (n = 21/85; 24.7 %), choledochointestinostomy and hepaticointestinostomy (n = 1/85; 1.2 %).The complication rate was 25 % (n = 26) - the spectrum comprised stent dislocation (n = 11), perforation (n = 1), pain (n = 2), hemorrhage (n = 6), biliary ascites/leakage (n = 3) and bilioma/liver abscess (n = 3; major complication rate, n = 12/68 - 17.6 %). Re-interventions were required in 19 patients (24 interventions in total). EUS-BD can be considered an elegant and safe alternative to PTCD or reoperation for failed ERCP to achieve the necessary drainage of the biliary system even in underlying benign diseases. An interventional EUS-based internal procedure can resolve cholestasis, avoid PTCD or reoperation, and thus improve quality of life. Due to the often complex (pathological and/or postoperative) anatomy, EUS-BD should only be performed in centers with interventional endoscopy/EUS experience including adequate abdominal surgery and interventional radiology expertise in the background. This enables adequately adapted therapeutic management in the event of challenging complications. It seems appropriate to conduct further studies with larger numbers of cases to systematize the approach and peri-interventional management and to successively develop specific equipment.

Füldner F ，Meyer F ，Will U 《-》

EUS-Guided Biliary Drainage for Unresectable Malignant Biliary Obstruction: 10-Year Experience of 99 Cases at a Single Center.

Kanno Y ，Koshita S ，Ogawa T ，Masu K ，Kusunose H ，Sakai T ，Murabayashi T ，Hasegawa S ，Kozakai F ，Yonamine K ，Kawakami Y ，Fujii Y ，Horaguchi J ，Noda Y ，Ito K ... -  《-》