Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Bile Duct Cancer; Liver Cancer
• Intervention / Treatment: Device: 'Intra-luminal radiofrequency ablation (Habib EndoHPB)

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival benefit	whether survival benefit is conferred to patients in the study at 3 months	up to 3 months
survival benefit	whether survival benefit is conferred to patients in the study at 6 months	up to 6 months
survival benefit	whether survival benefit is conferred to patients in the study at 12 months	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the recurrence of bile duct obstruction and jaundice	To analyze the recurrence of bile duct obstruction and jaundice.	up to 3 years
potential treatment-related complications	To analyze potential treatment-related complications	up to 3 years
repeated biliary interventions	To analyze the number of repeated biliary interventions	up to 3 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Kai-Wen Huang, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: radiofrequency ablation; malignant biliary stenosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Constriction, Pathologic; Cholangiocarcinoma; Bile Duct Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Anticonvulsants; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Phenobarbital
• Other Study ID Numbers: 201604030DIPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No