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Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841800
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Bile Duct Cancer Pancreatic Cancer Device: 'Intra-luminal radiofrequency ablation (Habib EndoHPB) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
Study Start Date : June 2016
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : May 10, 2019


Arm Intervention/treatment
Experimental: Intra-luminal radiofrequency ablation
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.
Device: 'Intra-luminal radiofrequency ablation (Habib EndoHPB)
endobiliary radiofrequency ablation device




Primary Outcome Measures :
  1. survival benefit [ Time Frame: up to 3 months ]
    whether survival benefit is conferred to patients in the study at 3 months

  2. survival benefit [ Time Frame: up to 6 months ]
    whether survival benefit is conferred to patients in the study at 6 months

  3. survival benefit [ Time Frame: up to 12 months ]
    whether survival benefit is conferred to patients in the study at 12 months


Secondary Outcome Measures :
  1. the recurrence of bile duct obstruction and jaundice [ Time Frame: up to 3 years ]
    To analyze the recurrence of bile duct obstruction and jaundice.

  2. potential treatment-related complications [ Time Frame: up to 3 years ]
    To analyze potential treatment-related complications

  3. repeated biliary interventions [ Time Frame: up to 3 years ]
    To analyze the number of repeated biliary interventions



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841800


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kai-Wen Huang, MD, PhD National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02841800    
Other Study ID Numbers: 201604030DIPD
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Taiwan University Hospital:
radiofrequency ablation
malignant biliary stenosis
Additional relevant MeSH terms:
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Bile Duct Neoplasms
Cholangiocarcinoma
Constriction, Pathologic
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Pathological Conditions, Anatomical
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers