PMID- 35665734
OWN - NLM
STAT- MEDLINE
DCOM- 20220608
LR  - 20230103
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 101
IP  - 22
DP  - 2022 Jun 3
TI  - Investigator initiated clinical trial to validate usefulness of specific system 
      for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary 
      obstruction (HG01).
PG  - e29408
LID - 10.1097/MD.0000000000029408 [doi]
LID - e29408
AB  - INTRODUCTION: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a 
      novel drainage option for patients with an inaccessible papilla. Although EUS-HGS 
      has clinical benefits in patients for whom endoscopic retrograde 
      cholangiopancreatography (ERCP) has failed, the rates of adverse events (AEs) 
      associated with EUS-HGS, such as bile peritonitis and stent migration, are higher 
      than for other procedures. The development of a dedicated system for EUS-HGS is 
      therefore desirable to reduce the rate of AEs. We developed a dedicated system 
      for EUS-HGS (HG01 system) which is composed of a 19-gauge needle, 0.025-inch 
      guidewire, a thin delivery system for tract dilation, and an antimigration metal 
      stent. This study is designed to evaluate the efficacy and safety of EUS-HGS 
      using the HG01 system in malignant biliary obstruction. METHODS/DESIGN: This is a 
      single-arm multicenter prospective study involving 40 patients across six 
      tertiary centers in Japan. Patients with an unresectable malignant biliary 
      obstruction in whom biliary drainage with ERCP failed, is not possible, or is 
      very difficult will be registered in the study. The primary endpoint is the 
      clinical success rate. The secondary endpoints are the technical success rate, 
      procedure-related AE rate, procedure time, procedure success rate using only the 
      HG01 system, stent patency rate, re-intervention success rate, re-intervention 
      method, survival rate, and distance of movement of the stent position. 
      DISCUSSION: We expect use of the HG01 system to reduce the rate of AEs during 
      EUS-HGS, especially bile leakage and stent migration. If the efficacy and safety 
      of EUS-HGS using the HG01 system is confirmed in the present study, it is likely 
      to be considered the first-choice device for use during EUS-HGS.
CI  - Copyright (c) 2022 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Itonaga, Masahiro
AU  - Itonaga M
AD  - Second Department of Internal Medicine, Wakayama Medical University, Wakayama, 
      Japan.
FAU - Kitano, Masayuki
AU  - Kitano M
AUID- ORCID: 0000-0001-6885-9223
AD  - Second Department of Internal Medicine, Wakayama Medical University, Wakayama, 
      Japan.
FAU - Isayama, Hiroyuki
AU  - Isayama H
AD  - Department of Gastroenterology, Graduate School of Medicine, Juntendo University, 
      Tokyo, Japan.
FAU - Takenaka, Mamoru
AU  - Takenaka M
AD  - Department of Gastroenterology and Hepatology, Kindai University Faculty of 
      Medicine, Osaka, Japan.
FAU - Ogura, Takeshi
AU  - Ogura T
AD  - The Second Department of Internal Medicine, Osaka Medical and Pharmaceutical 
      College, Takatsuki, Japan.
FAU - Yamashita, Yasunobu
AU  - Yamashita Y
AD  - Second Department of Internal Medicine, Wakayama Medical University, Wakayama, 
      Japan.
FAU - Fujisawa, Toshio
AU  - Fujisawa T
AD  - Department of Gastroenterology, Graduate School of Medicine, Juntendo University, 
      Tokyo, Japan.
FAU - Minaga, Kosuke
AU  - Minaga K
AD  - Department of Gastroenterology and Hepatology, Kindai University Faculty of 
      Medicine, Osaka, Japan.
FAU - Okuda, Atsushi
AU  - Okuda A
AD  - The Second Department of Internal Medicine, Osaka Medical and Pharmaceutical 
      College, Takatsuki, Japan.
FAU - Shimokawa, Toshio
AU  - Shimokawa T
AD  - Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
LA  - eng
GR  - 20315228/Japan Agency for Medical Research and Development/
GR  - no/Zeon/
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220603
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
SB  - IM
MH  - Cholangiopancreatography, Endoscopic Retrograde/methods
MH  - *Cholestasis/etiology/pathology/surgery
MH  - *Digestive System Abnormalities
MH  - Drainage/adverse effects/methods
MH  - Endosonography/methods
MH  - Humans
MH  - Prospective Studies
MH  - Stents/adverse effects
MH  - Ultrasonography, Interventional
PMC - PMC9276425
COIS- The authors declare that they have no competing interests.
EDAT- 2022/06/07 06:00
MHDA- 2022/06/09 06:00
PMCR- 2022/06/03
CRDT- 2022/06/06 14:53
PHST- 2022/04/06 00:00 [received]
PHST- 2022/04/21 00:00 [accepted]
PHST- 2022/06/06 14:53 [entrez]
PHST- 2022/06/07 06:00 [pubmed]
PHST- 2022/06/09 06:00 [medline]
PHST- 2022/06/03 00:00 [pmc-release]
AID - 00005792-202206030-00011 [pii]
AID - MD-D-22-02243 [pii]
AID - 10.1097/MD.0000000000029408 [doi]
PST - epublish
SO  - Medicine (Baltimore). 2022 Jun 3;101(22):e29408. doi: 
      10.1097/MD.0000000000029408.