Clinical trial · Interventional
Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
NCT04611100CI-TRIAL-00057297completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary stenting. Immediate complications as well as long term stent patency and patient survival would be studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Obstruction | — | UNRESOLVED | — |
| Hilar Cholangiocarcinoma | Hilar Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Conventional
- description
- Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation
- description
- Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice
- interventionNames
- Device: ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)
Primary outcomes (1)
- measure
- Biliary stent patency
- timeFrame
- up to 6 months
- description
- The duration between primary intervention and first recurrent increased in serum total bilirubin after intervention up to 6 months after the primary procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Hilar cholangiocarcinoma diagnosed by imaging or pathology * Considered unresectable or unfit for surgery * Presence of obstructive jaundice need endoscopic biliary drainage Exclusion Criteria: * History of unremovable metallic biliary stent placement * severe biliary stricture that the instrument was unable to pass through * unfit for endoscopic under conscious sedation * loss to follow up and loss contact within 6 months after intervention
References
Publications (5)
- BACKGROUNDSripa B, Pairojkul C. Cholangiocarcinoma: lessons from Thailand. Curr Opin Gastroenterol. 2008 May;24(3):349-56. doi: 10.1097/MOG.0b013e3282fbf9b3. PMID 18408464
- BACKGROUNDDoherty B, Nambudiri VE, Palmer WC. Update on the Diagnosis and Treatment of Cholangiocarcinoma. Curr Gastroenterol Rep. 2017 Jan;19(1):2. doi: 10.1007/s11894-017-0542-4. PMID 28110453
- BACKGROUNDHeimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available. PMID 28130846
- BACKGROUNDKim JH, Won HJ, Shin YM, Kim PN, Lee SG, Hwang S. Radiofrequency ablation for recurrent intrahepatic cholangiocarcinoma after curative resection. Eur J Radiol. 2011 Dec;80(3):e221-5. doi: 10.1016/j.ejrad.2010.09.019. Epub 2010 Oct 14. PMID 20950977
- BACKGROUNDRazumilava N, Gores GJ. Cholangiocarcinoma. Lancet. 2014 Jun 21;383(9935):2168-79. doi: 10.1016/S0140-6736(13)61903-0. Epub 2014 Feb 26. PMID 24581682