PMID- 32774461 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220416 IS - 1756-283X (Print) IS - 1756-2848 (Electronic) IS - 1756-283X (Linking) VI - 13 DP - 2020 TI - Endoscopic ultrasound-guided biliary drainage for malignant biliary obstruction with surgically altered anatomy: a multicenter prospective registration study. PG - 1756284820930964 LID - 10.1177/1756284820930964 [doi] LID - 1756284820930964 AB - BACKGROUND: Endoscopic treatment for malignant biliary obstruction (MBO) in patients bearing surgically altered anatomy (SAA) is not well-established. Although endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as a new treatment option for MBO, limited data are available regarding the efficacy and safety of EUS-BD in patients with SAA. We conducted a multicenter prospective registration study to evaluate the efficacy and safety of EUS-BD in this population. METHODS: This study involved 10 referral centers in Japan. Patients with SAA who were scheduled to receive EUS-BD for unresectable MBO between May 2016 and September 2018 were prospectively registered. The primary endpoint was technical success and the secondary outcomes were clinical success, procedure time, procedure-related adverse events (AEs), stent patency, and overall survival. RESULTS: In total, 40 patients were prospectively enrolled. The surgical reconstruction methods were gastrectomy with Roux-en-Y reconstruction (47.5%), gastrectomy with Billroth-II reconstruction (15%), pancreaticoduodenectomy (27.5%), and hepaticojejunostomy with Roux-en-Y reconstruction (10%). EUS-BD was performed for primary biliary drainage in 31 patients and for rescue biliary drainage in nine patients. Transmural stenting alone (60%), antegrade stenting alone (5%), and a combination of the two techniques (35%) were selected for patients treated with EUS-BD. Technical and clinical success rates were 100% (95% confidence interval, 91.2-100.0%) and 95% (95% confidence interval, 83.1-99.4%), respectively. Mean procedure time was 36.5 min. Early AEs were noted in six patients (15%): three self-limited bile leak, one bile peritonitis, and two pneumoperitonea. Late AEs occurred in six patients (15%): one jejunal ulcer and five stent occlusions. Stent patency rate after 3 months of survival was 95.7% (22/23). Median overall survival was 96 days. CONCLUSION: EUS-BD for MBO in patients with SAA appears to be effective and safe not only as a rescue drainage technique after failed endoscopic retrograde cholangiography but also as a primary drainage technique. CLINICAL TRIAL REGISTRATION: UMIN000022101. CI - (c) The Author(s), 2020. FAU - Minaga, Kosuke AU - Minaga K AD - Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan. FAU - Takenaka, Mamoru AU - Takenaka M AD - Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan. FAU - Ogura, Takeshi AU - Ogura T AUID- ORCID: 0000-0003-2916-6568 AD - Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan. FAU - Tamura, Takashi AU - Tamura T AD - Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan. FAU - Kuroda, Taira AU - Kuroda T AD - Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, To-on, Japan. FAU - Kaku, Toyoma AU - Kaku T AD - Department of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. FAU - Uenoyama, Yoshito AU - Uenoyama Y AD - Department of Gastroenterology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan. FAU - Noguchi, Chishio AU - Noguchi C AD - Department of Gastroenterology, Shinbeppu Hospital, Beppu, Japan. FAU - Nishikiori, Hidefumi AU - Nishikiori H AD - Department of Gastroenterology, Oita San-ai Medical Center, Oita, Japan. FAU - Imai, Hajime AU - Imai H AD - Department of Gastroenterology, Minami Wakayama Medical Center, Tanabe, Japan. FAU - Sagami, Ryota AU - Sagami R AD - Department of Gastroenterology, New Tokyo Hospital, Matsudo, Chiba. FAU - Fujimori, Nao AU - Fujimori N AD - Department of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. FAU - Higuchi, Kazuhide AU - Higuchi K AD - Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan. FAU - Kudo, Masatoshi AU - Kudo M AD - Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan. FAU - Chiba, Yasutaka AU - Chiba Y AD - Clinical Research Center, Kindai University Hospital, Osaka-Sayama, Japan. FAU - Kitano, Masayuki AU - Kitano M AUID- ORCID: 0000-0001-6885-9223 AD - Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Wakayama 641-8509, Japan. LA - eng PT - Journal Article DEP - 20200729 PL - England TA - Therap Adv Gastroenterol JT - Therapeutic advances in gastroenterology JID - 101478893 PMC - PMC7391429 OTO - NOTNLM OT - EUS OT - EUS-guided biliary drainage OT - endoscopic ultrasound OT - interventional EUS OT - surgically altered anatomy COIS- Conflict of interest: The authors declare that there is no conflict of interest. EDAT- 2020/08/11 06:00 MHDA- 2020/08/11 06:01 PMCR- 2020/07/29 CRDT- 2020/08/11 06:00 PHST- 2019/11/21 00:00 [received] PHST- 2020/05/11 00:00 [accepted] PHST- 2020/08/11 06:00 [entrez] PHST- 2020/08/11 06:00 [pubmed] PHST- 2020/08/11 06:01 [medline] PHST- 2020/07/29 00:00 [pmc-release] AID - 10.1177_1756284820930964 [pii] AID - 10.1177/1756284820930964 [doi] PST - epublish SO - Therap Adv Gastroenterol. 2020 Jul 29;13:1756284820930964. doi: 10.1177/1756284820930964. eCollection 2020.