None listed
Conditions
Interventions
Procedure/Surgery : In patients undergoing ID-RFA for malignant biliary strictures, we will evaluate the patterns and frequencies of complications associated with temperature-controlled and power-cont
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older with histologically or radiologically confirmed malignant tumors involving the bile duct. 2. Patients presenting with clinical symptoms of biliary obstruction, or those with radiologically confirmed biliary obstruction and proximal bile duct dilation secondary to malignant tumors, deemed malignant based on the clinical judgment of the attending physician (target lesions include pancreatic cancer, bile duct cancer, gallbladder cancer, ampullary cancer, liver cancer, and gastrointestinal cancers, or metastatic lymph nodes that may contribute to biliary obstruction). 3. Patients who are not candidates for radical surgery due to advanced-stage disease or other underlying medical conditions.
Exclusion criteria
Exclusion criteria: Hilar bile duct obstruction involving both intrahepatic bile ducts (Bismuth type II-IV). Patients ineligible for ERCP due to duodenal obstruction, underlying medical conditions, drug hypersensitivity, or other factors. Uncontrolled coagulation disorders (PT-INR >1.5; normal 0.85-1.25, platelet count < 60,000/mm³; normal 150,000-450,000/mm³). Patients unable to discontinue dual antiplatelet therapy (e.g., those with coronary artery disease who have undergone coronary artery stent placement within the past year). Patients with decompensated liver cirrhosis, classified as Child-Pugh class C. Patients undergoing renal replacement therapy due to renal dysfunction. Cases with altered anatomical structures of the bile duct due to prior surgical procedures. Inability to access the duodenal papilla with the duodenoscope, or failure of selective bile duct cannulation. Pregnancy or breastfeeding. Patients with poor performance status (ECOG =3). Patients who do not consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total adverse event rate after the index ERCP | — |
Secondary
| Measure | Time frame |
|---|---|
| Total early adverse event rate (=30 days) after the index ERCP;Severe AE rate within 30 days | — |
Countries
Korea, Republic of
Contacts
Public ContactMin Je Sung
Bundang CHA General Hospital
Outcome results
None listed