Do Hyun Park1, Tae Hoon Lee2, Woo Hyun Paik3, Jun-Ho Choi4, Tae Jun Song1, Sang Soo Lee1, Dong-Wan Seo1, Sung Koo Lee1, Myung-Hwan Kim1. 1. Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. 2. Department of Internal Medicine, Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, Republic of Korea. 3. Department of Internal Medicine, Inje University Ilsan Paik Hospital, Ilsan, Republic of Korea. 4. Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.
Abstract
BACKGROUND AND AIMS: EUS-guided biliary drainage (EUS-BD) has been proposed as an alternative for patients after failed ERCP. To date, the evaluation of dedicated device for one-step EUS-BD has been limited. To determine feasibility and safety of a newly designed 7F stent introducer with tapered metal tip as a push-type dilator for one-step metal stent placement without additional fistula dilation in EUS-BD. METHODS:Thirty-two patients with malignant biliary obstruction and failed ERCP were randomly assigned to a dedicated stent introducer with a modified hybrid metal stent (DH group, n = 16) or a conventional 8.5F biliary metal stent introducer with a fully covered metal stent (FC group, n = 16). The technical success, procedural times, clinical success rate, and adverse event rates were evaluated. RESULTS: One-step technical success without additional fistula dilation in the DH was 88% (14/16). Multi-step process in a stent placement was performed in all patients of the FC group. The procedural time in the DH was significantly shorter than the FC (10 vs. 15 min, P = 0.007). No difference in overall technical or clinical success was seen between the groups. The rate of an early adverse event was common in the FC compared with the DH (31.3% [5/16] in the FC vs. 6.3% [1/16] in the DH, P = 0.172), although not statistically significant. CONCLUSIONS: A dedicated device for one-step EUS-BD may be technically feasible, safe, and shorten the procedural times with less chance of an additional fistula dilation process, resulting in a potential reduction of the early adverse events.
RCT Entities:
BACKGROUND AND AIMS: EUS-guided biliary drainage (EUS-BD) has been proposed as an alternative for patients after failed ERCP. To date, the evaluation of dedicated device for one-step EUS-BD has been limited. To determine feasibility and safety of a newly designed 7F stent introducer with tapered metal tip as a push-type dilator for one-step metal stent placement without additional fistula dilation in EUS-BD. METHODS: Thirty-two patients with malignant biliary obstruction and failed ERCP were randomly assigned to a dedicated stent introducer with a modified hybrid metal stent (DH group, n = 16) or a conventional 8.5F biliary metal stent introducer with a fully covered metal stent (FC group, n = 16). The technical success, procedural times, clinical success rate, and adverse event rates were evaluated. RESULTS: One-step technical success without additional fistula dilation in the DH was 88% (14/16). Multi-step process in a stent placement was performed in all patients of the FC group. The procedural time in the DH was significantly shorter than the FC (10 vs. 15 min, P = 0.007). No difference in overall technical or clinical success was seen between the groups. The rate of an early adverse event was common in the FC compared with the DH (31.3% [5/16] in the FC vs. 6.3% [1/16] in the DH, P = 0.172), although not statistically significant. CONCLUSIONS: A dedicated device for one-step EUS-BD may be technically feasible, safe, and shorten the procedural times with less chance of an additional fistula dilation process, resulting in a potential reduction of the early adverse events.
Authors: A Hedjoudje; A Sportes; S Grabar; A Zhang; S Koch; L Vuitton; F Prat Journal: United European Gastroenterol J Date: 2018-10-26 Impact factor: 4.623
Authors: Won Jae Yoon; Do Hyun Park; Jun Ho Choi; Sunguk Jang; Jason Samarasena; Tae Hoon Lee; Woo Hyun Paik; Dongwook Oh; Tae Jun Song; Joon Hyuk Choi; Kazuo Hara; Takuji Iwashita; Manuel Perez-Miranda; John G Lee; Enrique Vazquez-Sequeiros; Itaru Naitoh; Juan J Vila; William R Brugge; Mamoru Takenaka; Sang Soo Lee; Dong-Wan Seo; Sung Koo Lee; Myung-Hwan Kim Journal: Endosc Ultrasound Date: 2019 May-Jun Impact factor: 5.628