Clinical trial NCT02841800: Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
Official title: Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Bile Duct Cancer
Pancreatic Cancer
Keywords: radiofrequency ablation
malignant biliary stenosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The HabibTM EndoHPB (EMcision Ltd., UK) catheter which was used for the endobiliary radiofrequency ablation (RFA) treatment is an endoscopic bipolar catheter designed to ablate tissue in malignant tumors within luminal structures. HabibTM EndoHPB has Food and Drug Administration (FDA) and European Conformity approval for such indications. It has also approved by Ministry of Health and Welfare in 2016. In this study, the investigators will perform intra-luminal RFA for 20 inoperable patients with malignant biliary stenosis. HabibTM EndoHPB will be deployed via an endoscopic retrograde cholangiopancreatography (ERCP) route. By using radiofrequency energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes occluded. If stent occlusion occurs in a participant during the follow up period, the participant will be reassessed and investigations will be used to determine cause of stent occlusion and whether it is appropriate to repeat RFA treatment. The aim will be to detect an improvement in survival and safety in the treated patients compared to patient receiving palliative treatment recorded in literatures.

Eligibility criteria: 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.

Primary outcomes:
measure: survival benefit
timeFrame: up to 3 months
measure: survival benefit
timeFrame: up to 6 months
measure: survival benefit
timeFrame: up to 12 months
Secondary outcomes:
measure: the recurrence of bile duct obstruction and jaundice
timeFrame: up to 3 years
measure: potential treatment-related complications
timeFrame: up to 3 years
measure: repeated biliary interventions
timeFrame: up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Kai-Wen Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: