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

Malignant Biliary Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169398
• Other study ID #: CRE-2021.447
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Anthony Teoh, FRCSEd
• Phone: 35052956
• Email: anthonyteoh[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Malignant Biliary Obstruction

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Department of Surgery, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & 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. — View Citation

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 manageme — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event	a life-threatening or severe event requiring endoscopic and/or surgical intervention, transfusion or IV/IM antibiotics	30 day
Secondary	Number of patients with technical success	transmural placement of the stent across the stomach or duodenum into the bile duct	1 day
Secondary	Number of patients with Clinical success	decrease of >20% bilirubin from baseline level	7 days
Secondary	Stent patency	the period between stent insertion and stent occlusion or stent removal	1 year