Research Report
Copyright ©2014 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 21, 2014; 20(19): 5859-5866
Published online May 21, 2014. doi: 10.3748/wjg.v20.i19.5859
A pilot proof-of-concept study of a modified device for one-step endoscopic ultrasound-guided biliary drainage in a new experimental biliary dilatation animal model
Tae Hoon Lee, Jun Hyuck Choi, Sang Soo Lee, Hyun Deuk Cho, Dong Wan Seo, Sang-Heum Park, Sung Koo Lee, Myung-Hwan Kim, Do Hyun Park
Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea
Jun Hyuck Choi, Sang Soo Lee, Dong Wan Seo, Sung Koo Lee, Myung-Hwan Kim, Do Hyun Park, Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Seoul 138-736, South Korea
Hyun Deuk Cho, Department of Pathology, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea
Author contributions: Lee TH and Choi JH are equally contributed to this paper; The concept of this study was proposed by Park DH; Lee TH, Choi JH and Park DH performed the procedures; Cho HD confirmed pathologic examination; Lee SS, Seo DW, Park SH, Lee SK and Kim MH reviewed and edited the manuscript; Lee TH and Park DH drafted the initial manuscript; all authors approved the final manuscript before submission.
Supported by the Soonchunhyang University Research Fund, a research grant (2013-7202) from the Asan Institute for Life Sciences, Asan Medical Center and the National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders
Correspondence to: Do Hyun Park, MD, PhD, Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, 388-1 Pungnap-2dong, Songpagu, Seoul 138-736, South Korea. dhpark@amc.seoul.kr
Telephone: +82-2-30103180 Fax: +82-2-4855782
Received: January 10, 2014
Revised: January 29, 2014
Accepted: March 6, 2014
Published online: May 21, 2014
Processing time: 127 Days and 17.3 Hours
Abstract

AIM: To evaluate the technical feasibility of a modified tapered metal tip and low profile introducer for one-step endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) in a new experimental biliary dilatation porcine model.

METHODS: A novel dedicated device for one-step EUS-guided biliary drainage system (DEUS) introducer has size 3F tapered catheter with size 4F metal tip for simple puncture of the intestinal wall and liver parenchyma without graded dilation. A self-expandable metal stent, consisting of both uncovered and nitinol-covered portions, was preloaded into DEUS introducer. After establishment of a biliary dilatation model using endoscopic hemoclips or band ligation with argon plasma coagulation in 9 mini-pigs, EUS-BD using a DEUS was performed following 19-G needle puncture without the use of fistula dilation devices.

RESULTS: One-step EUS-BD was technically successful in seven pigs [7/9 (77.8%) as intention to treat] without the aid of devices for fistula dilation from the high body of stomach or far distal esophagus to the intrahepatic (n = 2) or common hepatic (n = 5) duct. Primary technical failure occurred in two cases that did not show adequate biliary dilatation. In seven pigs with a successful bile duct dilatation, the technical success rate was 100% (7/7 as per protocol). Median procedure time from confirmation of the dilated bile duct to successful placement of a metallic stent was 10 min (IQR; 8.9-18.1). There were no immediate procedure-related complications.

CONCLUSION: Modified tapered metal tip and low profile introducer may be technically feasible for one-step EUS-BD in experimental porcine model.

Keywords: Endoscopic ultrasound; Biliary drainage; Biliary dilation; Feasibility; Complications

Core tip: Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) has been restricted due to limited data and dedicated devices to perform safely without multi-step processes. We report a pilot study of a modified tapered metal tip and low profile introducer for one-step EUS-BD in a new experimental biliary dilatation porcine model. EUS-guided hepaticoenterostomy using a novel dedicated device for one-step EUS-BD system (DEUS) in an experimental bile duct dilatation porcine model might be technically feasible and effective. One-step stent insertion and deployment precluded the need for additional fistula dilation devices for graded dilation or needle cautery incision, without involving complex procedures or DEUS-related complications.