None listed
Conditions
Interventions
Medical Device : This intervention group includes patients with malignant biliary obstruction who failed or were unsuitable for ERCP. EUS-guided hepaticogastrostomy (EUS-HGS) using a Twist stent will
Sponsors
Hallym University Medical Center-Dongtan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Adults aged 19 years or older (male or female) with biliary obstruction caused by histologically confirmed malignant tumors ?Patients for whom Endoscopic retrograde cholangiopancreatography is technically difficult or has failed ?Patients who are willing to participate in the clinical trial, comply with the treatment and procedures, and attend all follow-up visits ?Patients who have received a full explanation of the purpose, methods, and potential effects of the clinical trial and have voluntarily signed the written informed consent form
Exclusion criteria
Exclusion criteria: ?Women of childbearing potential who are unable to use appropriate contraceptive methods (e.g., hormonal contraception, intrauterine devices, vasectomy, tubal ligation, condoms), or who are pregnant or breastfeeding ?Patients with bleeding disorders (platelet count < 50,000/µL) ?Patients with chronic obstructive or restrictive pulmonary disease that includes dyspnea at rest ?Patients with an expected life expectancy of less than 3 months ?Patients who have participated in another clinical trial involving drugs or medical devices within the past 3 months ?Patients deemed unsuitable for participation in this clinical trial for other medical reasons at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical success;Stent cumulative patency;Stent patency period;Mean survival during 3 months after stent procedure | — |
Countries
Korea, Republic of
Contacts
Public ContactSe Woo Park
Hallym University Medical Center-Dongtan
Outcome results
None listed