NIPH Clinical Trials Search

A Comparative Study of Plastic and Metal Stents for Endoscopic Ultrasound-Guided Hepaticogastrostomy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients with unresectable malignant biliary stricture planned for EUS-HGS
Date of first enrollment	02/02/2026
Target sample size	84
Countries of recruitment
Study type	Interventional
Intervention(s)	Group A: EUS-HGS using a self-expanding metal stent (SEMS) Group B: EUS-HGS using a plastic stent (PS)

Outcome(s)

Primary Outcome	Time to recurrent biliary obstruction (TRBO) until 180 days after treatment
Secondary Outcome	(1) Technical success rate (2) Clinical success rate (3) The cumulative incidence of RBO during the overall survival (4) Time to RBO during the overall survival (5) Adverse event rate (6) Procedure time (7) Re-intervention success rate (8) Overall survival (OS) (9) Rate of chemotherapy administration after biliary drainage (10) Total medical costs related to treatment for biliary obstruction

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	(1) Patients aged 20 years or older at the time of consent. (2) Patients who have been pathologically diagnosed with malignancy or are strongly suspected of having malignancy based on imaging studies. (3) Patients scheduled to undergo EUS-guided hepaticogastrostomy (EUS-HGS) for unresectable malignant biliary stricture. (4) Patients expected to survive for more than 3 months after treatment. (5) Patients who undergo EUS-HGS as the initial drainage treatment or as a secondary drainage treatment following failure of the initial procedure. (6) Patients who have provided written informed consent.
Exclude criteria	(1) Patients judged to be unsuitable for endoscopic treatment. (2) Patients with a history of left hepatic lobectomy. (3) Patients who have undergone total gastrectomy. (4) Patients diagnosed with perihilar cholangiocarcinoma classified as Bismuth type 3b or 4. (5) Patients with an ECOG Performance Status of 4. (6) Patients with uncontrolled ascites. (7) Patients with severe comorbidities (cardiac, pulmonary, renal, or hepatic diseases), generally corresponding to ASA Physical Status > 4 or higher. (8) Patients with bleeding tendency (defined as PT-INR >1.5 or platelet count < 50,000/uL) (9) Patients with PTBD tubes in place at the time of consent (10) Patients deemed inappropriate for inclusion by the principal or sub-investigator for any other reason.