EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent

EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a malignant bile duct obstruction but the papilla is inaccessible or if the first of the duodenum is infiltrated by tumor. Recently, a novel dedicated HGS (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) has become available, the stent has a novel design to that prevents the stent from migration, further improving the safety.

The aim of the current study is to evaluate the feasibility and outcomes of the novel lumen apposing stent for EUS-guided HGS. The hypothesis is that the device is safe and effective.

Study Overview

• Status: Recruiting
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Device: EUS-guided hepaticogastrostomy

Detailed Description

This is a prospective feasibility study enrolling patients suffering from malignant biliary obstruction with failed or anticipated difficult ERCP. Consecutive patients satisfying the inclusion criteria would be recruited.

EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent. The MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) is a novel device designed for hepaticogastrostomy. The stent is a partially covered metal stent made by nitinol covered with silicone. One end of the stent is uncovered and designed for placement in the intrahepatic ducts. The other end has a self-folding design that creates a flange and prevents migration of the stent outside the stomach. The stent diameter is either 8 or 10mm and the length can be 6,8,10 or 12cm long.

Outcome parameters include safety, technical and clinical success

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony Teoh, FRCSEd; Phone Number: 35052956; Email: anthonyteoh@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Zero Chung; Phone Number: 35052956; Email: zerochung@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Surgery, Prince of Wales Hospital
    • Principal Investigator: Anthony YB Teoh
    • Contact: Anthony YB Teoh, FRCSEd(Gen); Phone Number: 35052956; Email: anthonyteoh@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. >= 18 years of age
2. Anatomically feasible for EUS-guided hepatico-gastrostomy
3. Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
4. Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis)
5. Written informed consent (and assent when applicable) obtained from subject.

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
2. Coagulopathic patients (INR>1.5, platelets <50,000)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS-guided hepaticogastrostomy; EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea).	Device: EUS-guided hepaticogastrostomy; EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	a life-threatening or severe event requiring endoscopic and/or surgical intervention, transfusion or IV/IM antibiotics	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with technical success	transmural placement of the stent across the stomach or duodenum into the bile duct	1 day
Number of patients with Clinical success	decrease of >20% bilirubin from baseline level	7 days
Stent patency	the period between stent insertion and stent occlusion or stent removal	1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

General Publications

• Ogura T, Ueno S, Okuda A, Nishioka N, Yamada M, Matsuno J, Ueshima K, Yamamoto Y, Higuchi K. Technical feasibility and safety of one-step deployment of EUS-guided hepaticogastrostomy using an 8-mm diameter metal stent with a fine-gauge stent delivery system (with video). Endosc Ultrasound. 2021 Sep-Oct;10(5):355-360. doi: 10.4103/EUS-D-20-00206.
• Teoh AYB, Dhir V, Kida M, Yasuda I, Jin ZD, Seo DW, Almadi M, Ang TL, Hara K, Hilmi I, Itoi T, Lakhtakia S, Matsuda K, Pausawasdi N, Puri R, Tang RS, Wang HP, Yang AM, Hawes R, Varadarajulu S, Yasuda K, Ho LKY. Consensus guidelines on the optimal management in interventional EUS procedures: results from the Asian EUS group RAND/UCLA expert panel. Gut. 2018 Jul;67(7):1209-1228. doi: 10.1136/gutjnl-2017-314341. Epub 2018 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Malignant Biliary Obstruction; EUS-biliary drainage; EUS-guided hepaticogastrostomy
• Other Study ID Numbers: CRE-2021.447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No