NCT05169398 EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent
| NCT ID | NCT05169398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Malignant Biliary Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-01-15 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-01-15 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05169398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Biliary Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05169398 currently recruiting?
Yes, NCT05169398 is actively recruiting participants. Contact the research team at anthonyteoh@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT05169398 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05169398 clinical trial?
NCT05169398 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 20 participants.