NCT05169398

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2022Nov 2026

First Submitted

Initial submission to the registry

November 12, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

November 12, 2021

Last Update Submit

March 19, 2026

Conditions

Malignant Biliary Obstruction

Keywords

Malignant Biliary ObstructionEUS-biliary drainageEUS-guided hepaticogastrostomy

Outcome Measures

Primary Outcomes (1)

  • Adverse event

    a life-threatening or severe event requiring endoscopic and/or surgical intervention, transfusion or IV/IM antibiotics

    30 day

Secondary Outcomes (3)

  • Number of patients with technical success

    1 day

  • Number of patients with Clinical success

    7 days

  • Stent patency

    1 year

Study Arms (1)

EUS-guided hepaticogastrostomy

EXPERIMENTAL

EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea).

Device: EUS-guided hepaticogastrostomy

Interventions

EUS-guided hepaticogastrostomyDEVICE

EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea)

EUS-guided hepaticogastrostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34427190BACKGROUND

  • 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.

    PMID: 29463614RESULT

Central Study Contacts

Anthony Teoh, FRCSEd

CONTACT

35052956anthonyteoh@surgery.cuhk.edu.hk

Zero Chung

CONTACT

35052956zerochung@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

December 27, 2021

Study Start

January 15, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)