Back to resultsIntra-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
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring radiofrequency ablation, malignant biliary stenosis
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.
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
NCT ID
NCT02841800
First Posted
July 19, 2016
Last Updated
August 2, 2019
Sponsor
National Taiwan University Hospital
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
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