Safety of skipping the tract dilation step for EUS-guided biliary drainage in patients with unresectable malignant biliary obstruction (with video).

Thin delivery system stents can be inserted directly without the need for a tract dilation step and are expected to reduce bile leakage during endoscopic ultrasound-guided biliary drainage (EUS-BD). The present study retrospectively compared the safety and efficacy of EUS-BD using a thin metal stent (< 7.5 Fr) with those of EUS-BD using a conventional stent (≥ 7.5 Fr). The present study enrolled 112 patients who underwent EUS-BD using metal stents for unresectable malignant biliary obstruction between April 2016 and July 2022. The primary endpoint was the rate of adverse events (AEs). The secondary endpoints were clinical success rate, procedure time, procedure success rate in the absence of the tract dilation step, recurrent biliary obstruction rate, time to biliary obstruction, and overall survival. Risk factors associated with early AEs were also evaluated. The rate of early AEs was significantly lower (12% vs. 35%, P = 0.013) and the procedure success without the tract dilation step was significantly higher (82% vs. 33%, P < 0.001) in the thin than in the conventional delivery system stent group. None of the other secondary endpoints differed significantly between the two groups. Multivariate analysis showed that employing the tract dilation step during EUS-BD was a significant independent risk factor for early AEs (skipping vs. employing; HR, 9.66; 95% CI, 1.13-83.0, P = 0.028). Employing the tract dilation step during EUS-BD was a significant risk factor for early AEs. Metal stents with a delivery diameter < 7.5 Fr can be inserted directly without the tract dilation step, resulting in lower early AE rates.

Itonaga M ，Ashida R ，Emori T ，Hatamaru K ，Yamashita Y ，Kawaji Y ，Tamura T ，Tuda I ，Tamura T ，Koutani H ，Yamazaki H ，Shimokawa T ，Kitano M ... -  《-》

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 ... -  《-》

Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01).

Itonaga M ，Kitano M ，Isayama H ，Takenaka M ，Ogura T ，Yamashita Y ，Fujisawa T ，Minaga K ，Okuda A ，Shimokawa T ... -  《-》

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 ... -  《-》

Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in malignant distal bile duct obstruction using a self-expanding metal stent: Study protocol for a prospective European multicenter trial (PUMa trial).

Schmitz D ，Valiente CT ，Dollhopf M ，Perez-Miranda M ，Küllmer A ，Gornals J ，Vila J ，Weigt J ，Voigtländer T ，Redondo-Cerezo E ，von Hahn T ，Albert J ，Vom Dahl S ，Beyna T ，Hartmann D ，Franck F ，García-Alonso FJ ，Schmidt A ，Garcia-Sumalla A ，Arrubla A ，Joerdens M ，Kleemann T ，Tomo JRA ，Grassmann F ，Rudi J ... -  《PLoS One》