Endoscopic ultrasound-guided choledochoduodenostomy using a thin stent delivery system in patients with unresectable malignant distal biliary obstruction: A prospective multicenter study.

When endoscopic retrograde cholangiopancreatography (ERCP) fails in patients with malignant distal biliary obstruction, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is an alternative. It has high technical and clinical success rates, but also has high adverse event rates. This prospective cohort study was aimed to evaluate the clinical efficacy and safety of EUS-CDS with our newly developed partially covered self-expandable metal stent with a thin delivery system. Patients consisted of all consecutive patients in three tertiary referral centers with unresectable malignant distal obstruction in whom ERCP failed and in whom EUS-CDS with the thin delivery system was selected as the second-line approach. Rates of clinical success, technical success, technical success in cases not requiring fistulous tract dilation, adverse events, and stent dysfunction were determined. In the 20 patients, technical and clinical success rates were 95.0% (19/20) and 100% (19/19), respectively. In 31.6% (6/19), the delivery system was successfully inserted into the bile duct without requiring a fistulous-tract dilatation device. These patients had significantly shorter procedure times than patients requiring fistulous-tract dilatation (12.7 ± 3.1 vs 23.2 ± 2.1 min; P < 0.01). One patient (5.0%) who required fistulous dilation had an adverse event, which was managed conservatively. There were no procedure-related deaths. During follow up, four patients (21.1%) developed stent dysfunction. Reintervention was successful in all cases. The EUS-CDS approach had 95% technical and 100% clinical success rates, with adverse events reported in 5% of cases. EUS-CDS may become safer if efforts are made to avoid the dilation step (UMIN 000023938).

Itonaga M ，Kitano M ，Hatamaru K ，Tamura T ，Nuta J ，Kawaji Y ，Takenaka M ，Minaga K ，Kudo M ，Ogura T ，Higuchi K ，Chiba Y ... -  《-》

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 ... -  《-》

Endoscopic ultrasound-guided choledochoduodenostomies with fully covered self-expandable metallic stents.

Song TJ ，Hyun YS ，Lee SS ，Park DH ，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 ... -  《-》

Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial).

Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. gov, Number: NCT03870386.

Chen YI ，Sahai A ，Donatelli G ，Lam E ，Forbes N ，Mosko J ，Paquin SC ，Donnellan F ，Chatterjee A ，Telford J ，Miller C ，Desilets E ，Sandha G ，Kenshil S ，Mohamed R ，May G ，Gan I ，Barkun J ，Calo N ，Nawawi A ，Friedman G ，Cohen A ，Maniere T ，Chaudhury P ，Metrakos P ，Zogopoulos G ，Bessissow A ，Khalil JA ，Baffis V ，Waschke K ，Parent J ，Soulellis C ，Khashab M ，Kunda R ，Geraci O ，Martel M ，Schwartzman K ，Fiore JF Jr ，Rahme E ，Barkun A ... -  《-》