Clinical trial · Interventional
Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma
Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma: A Prospective, Single-arm, Multicenter Study
NCT06168292CI-TRIAL-00091184recruitingN/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)
\[Study objectives\] To evaluate the efficacy and safety of the combined treatment of radiotherapy and endoscopic intraductal radiofrequency ablation in patients with locoregional extrahepatic cholangiocarcinoma.
Conditions
Conditions (3)
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 Tract Carcinoma | Biliary Tract Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radio-frequency Ablation | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ID-RFA and Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- The clinical study will be conducted in the following order. Of patients with extrahepatic cholangiocarcinoma requiring biliary drainage, those who meet the inclusion criteria and consent to the study will be enrolled in the study and hospitalized to undergo endoscopic biliary drainage. The histologic or cytologic examination will be performed at the time of the first biliary drainage, and the extent of the cholangiocarcinoma lesion will be assessed during the procedure. After the diagnosis of extrahepatic cholangiocarcinoma, ID-RFA will be performed, and a biliary stent will be inserted for biliary drainage. Radiotherapy will be performed within 1 month of ID-RFA.
- interventionNames
- Procedure: ID-RFA and Radiotherapy
Primary outcomes (1)
- measure
- 2-year local control rate
- timeFrame
- At 2 years from the date of study enrollment
- description
- 2-year local control rate
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients 20 years of age or older, who voluntarily agree to participate in the study and sign the informed consent. 2. Patients with cytopathologically diagnosed inoperable extrahepatic cholangiocarcinoma Exclusion Criteria: 1. Patients who refuse to sign the informed consent 2. Patients with metastatic cancer (stage IV) or malignant ascites 3. Patients with intrahepatic cholangiocarcinoma 4. Patients who are unable to undergo endoscopic procedures as determined by the investigator. 5. Patients with a life expectancy of 3 months or less 6. Patients with ID-RFA contraindications: pacemaker, pregnancy, uncorrected bleeding tendency (PT INR \> 1.5, platelets \< 50,000/mm3)
References
Publications (12)
- RESULTPrezzano KM, Prasad D, Hermann GM, Belal AN, Alberico RA. Radiofrequency Ablation and Radiation Therapy Improve Local Control in Spinal Metastases Compared to Radiofrequency Ablation Alone. Am J Hosp Palliat Care. 2019 May;36(5):417-422. doi: 10.1177/1049909118819460. Epub 2018 Dec 13. PMID 30541334
- RESULTHiraki T, Gobara H, Iguchi T, Fujiwara H, Matsui Y, Kanazawa S. Radiofrequency ablation for early-stage nonsmall cell lung cancer. Biomed Res Int. 2014;2014:152087. doi: 10.1155/2014/152087. Epub 2014 Jun 3. PMID 24995270
- RESULTAutorino R, Mattiucci GC, Ardito F, Balducci M, Deodato F, Macchia G, Mantini G, Perri V, Tringali A, Gambacorta MA, Tagliaferri L, Giuliante F, Morganti AG, Valentini V. Radiochemotherapy with Gemcitabine in Unresectable Extrahepatic Cholangiocarcinoma: Long-term Results of a Phase II Study. Anticancer Res. 2016 Feb;36(2):737-40. PMID 26851032
- RESULTCho JH, Jeong S, Kim EJ, Kim JM, Kim YS, Lee DH. Long-term results of temperature-controlled endobiliary radiofrequency ablation in a normal swine model. Gastrointest Endosc. 2018 Apr;87(4):1147-1150. doi: 10.1016/j.gie.2017.09.013. Epub 2017 Sep 25. PMID 28958907
- RESULTKim EJ, Chung DH, Kim YJ, Kim YS, Park YH, Kim KK, Cho JH. Endobiliary radiofrequency ablation for distal extrahepatic cholangiocarcinoma: A clinicopathological study. PLoS One. 2018 Nov 15;13(11):e0206694. doi: 10.1371/journal.pone.0206694. eCollection 2018. PMID 30439965
- RESULTSofi AA, Khan MA, Das A, Sachdev M, Khuder S, Nawras A, Lee W. Radiofrequency ablation combined with biliary stent placement versus stent placement alone for malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2018 Apr;87(4):944-951.e1. doi: 10.1016/j.gie.2017.10.029. Epub 2017 Nov 3. PMID 29108980
- RESULTYang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.