Liver CancerNCT02841800
Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
A study testing 'Intra-luminal radiofrequency ablation (Habib EndoHPB) in people with Liver Cancer and Bile Duct Cancer, run by National Taiwan University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Liver Cancer, Bile Duct Cancer, Pancreatic Cancer
- What is being tested?
- 'Intra-luminal radiofrequency ablation (Habib EndoHPB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 10 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Liver Cancer, Bile Duct Cancer, Pancreatic Cancer
- Being tested
- 'Intra-luminal radiofrequency ablation (Habib EndoHPB)
- Keywords
- radiofrequency ablation, malignant biliary stenosis
- Medical subject headings
- Liver Neoplasms, Bile Duct Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Intra-luminal radiofrequency ablation (Habib EndoHPB)Device
endobiliary radiofrequency ablation device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 'Intra-luminal radiofrequency ablation (Habib EndoHPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival benefit
whether survival benefit is conferred to patients in the study at 3 months
Measured: up to 3 months
survival benefit
whether survival benefit is conferred to patients in the study at 6 months
Measured: up to 6 months
survival benefit
whether survival benefit is conferred to patients in the study at 12 months
Measured: up to 12 months
Secondary outcomes (3)
the recurrence of bile duct obstruction and jaundice
To analyze the recurrence of bile duct obstruction and jaundice.
Measured: up to 3 years
potential treatment-related complications
To analyze potential treatment-related complications
Measured: up to 3 years
repeated biliary interventions
To analyze the number of repeated biliary interventions
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion30 Aug 2018
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841800
- Sponsor's protocol ID
- 201604030DIPD
- Status last verified
- Jun 2019
- First submitted
- 19 Jul 2016
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
- ClinicalTrials.gov ID
- NCT02841800
- Acronym / sponsor ID
- 201604030DIPD
- Conditions
- Liver Cancer, Bile Duct Cancer, Pancreatic Cancer
- Keywords
- radiofrequency ablation, malignant biliary stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-luminal radiofrequency ablation | Experimental | Device: 'Intra-luminal radiofrequency ablation (Habib EndoHPB)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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must meet all of the following inclusion criteria to be eligible for this study:
Key exclusion criteria (8 listed)
- Patients presenting with any of the following will not be enrolled into this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Intra-luminal radiofrequency ablation (Habib EndoHPB)endobiliary radiofrequency ablation device | Device | Intra-luminal radiofrequency ablation |
Primary outcome
survival benefit
Time frame: up to 3 months
whether survival benefit is conferred to patients in the study at 3 months
survival benefit
Time frame: up to 6 months
whether survival benefit is conferred to patients in the study at 6 months
survival benefit
Time frame: up to 12 months
whether survival benefit is conferred to patients in the study at 12 months
3 secondary outcomes
the recurrence of bile duct obstruction and jaundice
Time frame: up to 3 years
potential treatment-related complications
Time frame: up to 3 years
repeated biliary interventions
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai-Wen Huang, MD, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 'Intra-luminal radiofrequency ablation (Habib EndoHPB) in people with Liver Cancer and Bile Duct Cancer, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival benefit (time frame: up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.