Clinical trial · Interventional
Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
- 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 biliary obstruction caused by hepatopancreatobiliary malignancies are suitable for surgical resection. Therefore, most patients with malignant biliary obstruction will need palliation of their obstructive jaundice to relieve the symptoms and prevent life threatening complications such as biliary sepsis. The endoscopic or percutaneous/transhepatic routes, such as endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC), and stents are accepted approaches for the relief of jaundice in malignant biliary obstruction. Improvement in the bilirubin level is also essential before palliative chemotherapy is considered in these patients. However, tumor ingrowth still remains a major cause of obstruction. In this trial, the investigators will use HabibTM EndoHPB (EMcision Ltd., UK) catheter which was used for the endobiliary radiofrequency ablation (RFA) treatment as a form of neoadjuvant therapy in hepatopancreatobiliary adenocarcinoma.
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 |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 'Intra-luminal radiofrequency ablation (Habib EndoHPB) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intra-luminal radiofrequency ablation
- description
- Intra-luminal radiofrequency ablation Admission for endoscopic retrograde cholangiopancreatography (ERCP) and stent placement after radiofrequency ablation. ERCP should be performed for 2 times with an interval of two months.
- interventionNames
- Device: 'Intra-luminal radiofrequency ablation (Habib EndoHPB)
Primary outcomes (3)
- measure
- survival benefit
- timeFrame
- up to 3 months
- description
- whether survival benefit is conferred to patients in the study at 3 months
- measure
- survival benefit
- timeFrame
- up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must meet all of the following inclusion criteria to be eligible for this study: 1. 20 Years and older. 2. The diagnosis of hepatopancreaticobiliary cancers with pathologic proven, and the diagnosis of hepatopancreaticobiliary cancers will be made by pathology / cytology or according to the American Association for the Study of Liver Diseases (AASLD) (2010) diagnostic criteria. 3. Participant unsuitable for surgical resection. Criteria for unresectability being based on metastatic disease or locally advanced. 4. Eastern Cooperative Oncology Group (ECOG) score of 0-1. 5. American Society of Anaesthesiologists (ASA) score ≤ 3. 6. Karnofsky score \>30. 7. Jaundice (bilirubin level over 10 mg/dL). Alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal. 8. Prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0. Platelet count ≥ 100 K/Μl. 9. Expected to survive more than 3 months. Exclusion Criteria: * Patients presenting with any of the following will not be enrolled into this study: 1. Under the age of 20 years old. 2. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception. 3. Known history of human immunodeficiency virus (HIV) infection. 4. Patients who have any serious or systemic disease that is not a good fit for this test. 5. Tumor occupying more than 50% of liver parenchyma 6. Any active metal implanted device (eg Pacemaker). 7. Guidewire cannot pass through the bile duct stenosis.
References
Publications (0)
Data not yet available