search
Back to results

Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis

Primary Purpose

Liver Cancer, Bile Duct Cancer, Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
'Intra-luminal radiofrequency ablation (Habib EndoHPB)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring radiofrequency ablation, malignant biliary stenosis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intra-luminal radiofrequency ablation

    Arm 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.

    Outcomes

    Primary Outcome Measures

    survival benefit
    whether survival benefit is conferred to patients in the study at 3 months
    survival benefit
    whether survival benefit is conferred to patients in the study at 6 months
    survival benefit
    whether survival benefit is conferred to patients in the study at 12 months

    Secondary Outcome Measures

    the recurrence of bile duct obstruction and jaundice
    To analyze the recurrence of bile duct obstruction and jaundice.
    potential treatment-related complications
    To analyze potential treatment-related complications
    repeated biliary interventions
    To analyze the number of repeated biliary interventions

    Full Information

    First Posted
    July 19, 2016
    Last Updated
    August 2, 2019
    Sponsor
    National Taiwan University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02841800
    Brief Title
    Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
    Official Title
    Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    August 30, 2018 (Actual)
    Study Completion Date
    May 10, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cancer, Bile Duct Cancer, Pancreatic Cancer
    Keywords
    radiofrequency ablation, malignant biliary stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intra-luminal radiofrequency ablation
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    'Intra-luminal radiofrequency ablation (Habib EndoHPB)
    Intervention Description
    endobiliary radiofrequency ablation device
    Primary Outcome Measure Information:
    Title
    survival benefit
    Description
    whether survival benefit is conferred to patients in the study at 3 months
    Time Frame
    up to 3 months
    Title
    survival benefit
    Description
    whether survival benefit is conferred to patients in the study at 6 months
    Time Frame
    up to 6 months
    Title
    survival benefit
    Description
    whether survival benefit is conferred to patients in the study at 12 months
    Time Frame
    up to 12 months
    Secondary Outcome Measure Information:
    Title
    the recurrence of bile duct obstruction and jaundice
    Description
    To analyze the recurrence of bile duct obstruction and jaundice.
    Time Frame
    up to 3 years
    Title
    potential treatment-related complications
    Description
    To analyze potential treatment-related complications
    Time Frame
    up to 3 years
    Title
    repeated biliary interventions
    Description
    To analyze the number of repeated biliary interventions
    Time Frame
    up to 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for this study: 20 Years and older. 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. Participant unsuitable for surgical resection. Criteria for unresectability being based on metastatic disease or locally advanced. Eastern Cooperative Oncology Group (ECOG) score of 0-1. American Society of Anaesthesiologists (ASA) score ≤ 3. Karnofsky score >30. Jaundice (bilirubin level over 10 mg/dL). Alanine transaminase (ALT) and aspartate transaminase (AST) < 5 x upper limit of normal. Prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0. Platelet count ≥ 100 K/Μl. Expected to survive more than 3 months. Exclusion Criteria: Patients presenting with any of the following will not be enrolled into this study: Under the age of 20 years old. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception. Known history of human immunodeficiency virus (HIV) infection. Patients who have any serious or systemic disease that is not a good fit for this test. Tumor occupying more than 50% of liver parenchyma Any active metal implanted device (eg Pacemaker). Guidewire cannot pass through the bile duct stenosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kai-Wen Huang, MD, PhD
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis

    We'll reach out to this number within 24 hrs