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Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis

NCT02841800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-08-05

No results posted yet for this study

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

Interventions

DEVICE

'Intra-luminal radiofrequency ablation (Habib EndoHPB)

endobiliary radiofrequency ablation device

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Kai-Wen Huang, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-08-30
Completion
2019-05-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02841800 on ClinicalTrials.gov