PMID- 37969165
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231117
IS  - 2303-9027 (Print)
IS  - 2226-7190 (Electronic)
IS  - 2226-7190 (Linking)
VI  - 12
IP  - 5
DP  - 2023 Sep-Oct
TI  - Prospective clinical trial of EUS-guided choledochoduodenostomy without fistula 
      dilation for malignant distal biliary obstruction.
PG  - 409-416
LID - 10.1097/eus.0000000000000009 [doi]
AB  - BACKGROUND AND OBJECTIVES: During EUS-guided choledochoduodenostomy (EUS-CDS), 
      fistula dilation before stent insertion is associated with adverse events (AEs), 
      such as bile leakage and peritonitis. We hypothesized that EUS-CDS without 
      fistula dilation using a novel self-expandable metal stent (SEMS) with a thin 
      delivery system could overcome this problem, and we conducted this study to 
      evaluate its feasibility and safety. METHODS: This was an open-label, single-arm, 
      phase II study at a single institution. We planned EUS-CDS without fistula 
      dilation using a fully covered SEMS with a 5.9-Fr delivery system for 
      unresectable malignant distal biliary obstruction. The primary outcome was 
      overall technical success. Secondary outcomes were technical success without 
      fistula dilation, procedure time, functional success, time to recurrent biliary 
      obstruction, and AEs. The planned sample size was 25 patients. RESULTS: In total, 
      24 patients were included in this study. In 21 patients, EUS-CDS was performed as 
      primary drainage. The overall technical success rate was 100% (24 of 24 
      patients). The technical success rate without fistula dilation was 96% (23 of 
      24). The median procedure time was 16 min (range, 10-66 min). The functional 
      success rate was 96% (23 of 24). The median time to recurrent biliary obstruction 
      was 148 days (95% confidence interval, 29-266 days). There were no 
      procedure-related AEs. Furthermore, computed tomography immediately after the 
      procedure showed no leakage of contrast medium into the abdominal cavity in any 
      patient. CONCLUSIONS: EUS-guided choledochoduodenostomy without fistula dilation 
      using a fully covered SEMS with a 5.9-Fr delivery system is feasible with a high 
      probability and can be achieved quickly while effectively preventing bile leakage 
      and peritonitis.
CI  - Copyright (c) 2023 The Author(s). Published by Wolters Kluwer on behalf of Scholar 
      Media Publishing.
FAU - Koga, Takehiko
AU  - Koga T
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
AD  - Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka 
      University, 7-45-1 Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan.
FAU - Hijioka, Susumu
AU  - Hijioka S
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Nagashio, Yoshikuni
AU  - Nagashio Y
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Maruki, Yuta
AU  - Maruki Y
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Maehara, Kosuke
AU  - Maehara K
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Murashima, Yumi
AU  - Murashima Y
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Kawasaki, Yuki
AU  - Kawasaki Y
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Takeshita, Kotaro
AU  - Takeshita K
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Yamada, Natsumi
AU  - Yamada N
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Yoshinari, Motohiro
AU  - Yoshinari M
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Hisada, Yuya
AU  - Hisada Y
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Harai, Shota
AU  - Harai S
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Kitamura, Hidetoshi
AU  - Kitamura H
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Kawahara, Shun
AU  - Kawahara S
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Ohba, Akihiro
AU  - Ohba A
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Morizane, Chigusa
AU  - Morizane C
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
FAU - Ishida, Yusuke
AU  - Ishida Y
AD  - Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka 
      University, 7-45-1 Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan.
FAU - Hirai, Fumihito
AU  - Hirai F
AD  - Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka 
      University, 7-45-1 Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan.
FAU - Okusaka, Takuji
AU  - Okusaka T
AD  - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center 
      Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
LA  - eng
PT  - Journal Article
DEP - 20230928
PL  - China
TA  - Endosc Ultrasound
JT  - Endoscopic ultrasound
JID - 101622292
PMC - PMC10631599
OTO - NOTNLM
OT  - Cholangiography
OT  - EUS
OT  - EUS-guided biliary drainage (EUS-BD)
OT  - EUS-guided choledochoduodenostomy (EUS-CDS)
OT  - Endosonography
COIS- The authors declare no conflicts of interest.
EDAT- 2023/11/16 06:45
MHDA- 2023/11/16 06:46
PMCR- 2023/09/28
CRDT- 2023/11/16 04:18
PHST- 2022/10/07 00:00 [received]
PHST- 2023/04/12 00:00 [accepted]
PHST- 2023/11/16 06:46 [medline]
PHST- 2023/11/16 06:45 [pubmed]
PHST- 2023/11/16 04:18 [entrez]
PHST- 2023/09/28 00:00 [pmc-release]
AID - EUSJ_230002 [pii]
AID - 10.1097/eus.0000000000000009 [doi]
PST - ppublish
SO  - Endosc Ultrasound. 2023 Sep-Oct;12(5):409-416. doi: 10.1097/eus.0000000000000009. 
      Epub 2023 Sep 28.