None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : 1) Intervention Group (RFA arm):
Procedure: On Day 0, endobiliary radiofrequency ablation (EB-RFA
7-10W, 80?, 120 sec) is performed followed by plastic stent insertion. At Month 3 (window: 2-4 months), repeated EB-RFA and stent exchange are performed.
Medication: Systemic chemotherapy with Gemcita
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologically or cytologically confirmed extrahepatic cholangiocarcinoma (eCCA) (2) Patients with unresectable disease due to tumor or patient factors (including refusal of surgery) (3) Patients requiring biliary drainage, evidenced by cholestasis on blood tests (elevated liver enzymes or bilirubin), radiologic biliary obstruction, or an existing biliary drainage tube (4) Patients scheduled to initiate Gemcitabine-Cisplatin-Durvalumab (GCD) combination therapy (5) Aged 19 years or older, regardless of sex (6) Patients who have provided written informed consent voluntarily after receiving a sufficient explanation of the study
Exclusion criteria
Exclusion criteria: (1) History of prior radiotherapy or systemic chemotherapy for the current eCCA (2) Presence of a previously inserted self-expandable metallic stent (SEMS) that cannot be endoscopically removed (3) Surgical anatomical alterations other than Billroth-I, or a history of prior biliary reconstruction surgery (4) History of chronic cholangitis, such as primary sclerosing cholangitis (PSC) or IgG4-related sclerosing cholangitis (5) Life expectancy of less than 3 months (6) Inability to undergo peroral endoscopy or inaccessible major duodenal papilla (7) Presence of absolute contraindications for the EB-RFA procedure (8) Current pregnancy or potential for pregnancy (9) Any other conditions that the investigator deems inappropriate for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Recurrent Biliary Obstruction (TRBO) and Progression-Free Survival (PFS);Procedural and clinical success rates, procedure-related adverse events, and number of re-interventions. | — |
Countries
Korea, Republic of
Contacts
Public ContactHuapyong Kang
Yonsei University Health System, Severance Hospital
Outcome results
None listed