Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis

NCT02841800 | Completed DMC

• 1 other identifier: 201604030DIPD
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Cancer; Bile Duct Cancer; Pancreatic Cancer

Keywords

radiofrequency ablation; malignant biliary stenosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• the recurrence of bile duct obstruction and jaundice

  up to 3 years

• potential treatment-related complications

  up to 3 years

• repeated biliary interventions

  up to 3 years

Study Arms (1)

Intra-luminal radiofrequency ablation

EXPERIMENTAL

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)

Interventions

'Intra-luminal radiofrequency ablation (Habib EndoHPB) DEVICE

endobiliary radiofrequency ablation device

Intra-luminal radiofrequency ablation

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Liver Neoplasms; Bile Duct Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Kai-Wen Huang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 22, 2016
• Study Start: June 1, 2016
• Primary Completion: August 30, 2018
• Study Completion: May 10, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share