Clinical trial · Interventional
Endobiliary RFA for Unresectable Malignant Biliary Strictures
Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
- 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)
Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.
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 |
|---|---|---|---|
| Ampullary Carcinoma | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation (RFA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endobiliary RFA group
- description
- 1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive endobiliary radiofrequency ablation (Endobiliary RFA) followed by plastic stent(s) placement. 2. Three months later, subjects will receive the second RFA therapy followed by biliary stents (plastic or SEMS) placement. 3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA
- interventionNames
- Procedure: Radiofrequency ablation (RFA)
- type
- NO_INTERVENTION
- label
- Control group
- description
- 1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive plastic biliary stent(s) placement only. 2. Three months later, subjects will receive the second endoscopic intervention for stents (plastic or SEMS) exchange. 3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Either gender greater than or equal to 18 years of age. * Cholangiocarcinoma or ampullary cancer unsuitable for surgical resection by staging, comorbidities or patient wishes. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced. * Biliary obstruction, Bilirubin \> 40umol/L at diagnosis * Subjects capable of giving informed consent * Life expectancy of at least 3 months * Histologically (preferred) or radiologically confirmed cholangiocarcinoma or ampullary cancer Exclusion Criteria: * Cardiac Pacemaker * Patient unstable for endoscopy * Inability to give informed consent * Coagulopathy (INR \> 2.0 or PTT \> 100 sec or platelet count \< 50,000) * Performance status ECOG ≥3 (confined to bed / chair \> 50% waking hours) * Active suppurative cholangitis * Complex stenoses will not be eligible for the trial * Patients without access to duodenum or ampulla are not candidates for ERCP and stenting * Malignant ascites * Presence of main portal vein thrombosis * Prior stents placement * Prior Billroth II or roux-en Y reconstruction * Inability to insert a guide wire across the malignant stricture * Pregnancy * Presence of other malignancy * Life expectancy \< 3months
References
Publications (1)
- DERIVEDGao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24. PMID 33359435