Health TrialsbyHealthPanel

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

ConditionMalignant Biliary Obstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>= 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)

Disqualifiers

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

Coagulopathic patients (INR>1.5, platelets <50,000)

Trial design

Design model

Single group

Treatments tested in this trial

  • EUS-guided hepaticogastrostomy

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: EUS-guided hepaticogastrostomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse event

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

Time frame
30 day

Secondary outcomes

1

Number of patients with technical success

transmural placement of the stent across the stomach or duodenum into the bile duct

Time frame
1 day
2

Number of patients with Clinical success

decrease of \>20% bilirubin from baseline level

Time frame
7 days
3

Stent patency

the period between stent insertion and stent occlusion or stent removal

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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