Obstruction of Biliary TreeNCT01543607
Endoscopic Therapy of Malignant Bile Duct Strictures
A study testing Radiofrequency ablation catheter (Habib EndoHBP) in people with Obstruction of Biliary Tree and Biliary Tract Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstruction of Biliary Tree, Biliary Tract Cancer, Biliary Tract Neoplasms
- What is being tested?
- Radiofrequency ablation catheter (Habib EndoHBP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented malignant biliary obstruction requiring ERCP guided stenting
Who cannot join
- Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
- Evidence of high-grade symptomatic duodenal obstruction
- Poor performance status
- Active suppurative cholangitis
- Complex stenoses will not be eligible for the trial
- Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
- Candidates for a Whipple resection
- Patients who do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study
Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.
Read the detailed description
As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. Three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. The study procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects will undergo routine follow up for their medical problems. No follow up visits are required as part of the study.
- Being tested
- Radiofrequency ablation catheter (Habib EndoHBP)
- Keywords
- Bile duct, Cholangiocarcinoma, Bile duct stenosis, Malignant bile duct obstruction, Malignant bile duct stricture, Radiofrequency ablation, RFA, Endoscopic RFA catheter, EndoHPB
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation catheter (Habib EndoHBP)Device
Also called Habib EndoHBP
Catheter placement into bile duct
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Radiofrequency ablation catheter Receives: Device: Radiofrequency ablation catheter (Habib EndoHBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Bile Leak After RFA Procedure
Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)
Measured: 2 years
Secondary outcomes (2)
Feasibility: Ease of the Radiofrequency Ablation Catheter Placement
Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter.
Measured: 2 years
Effectiveness: Change From Baseline in Bile Duct Diameter.
Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure. This will be measure as percentage change in improvement of the stricture.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstruction of Biliary TreeStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William R. Brugge, MD, Massachusetts General Hospital
- Investigators
- William R Brugge, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543607
- Sponsor's protocol ID
- 11-405
- Status last verified
- Mar 2017
- First submitted
- 15 Feb 2012
- Last updated
- 24 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study
- ClinicalTrials.gov ID
- NCT01543607
- Acronym / sponsor ID
- 11-405
- Keywords
- Bile duct, Cholangiocarcinoma, Bile duct stenosis, Malignant bile duct obstruction, Malignant bile duct stricture, Radiofrequency ablation, RFA, Endoscopic RFA catheter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.
Detailed description
As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. Three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. The study procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects will undergo routine follow up for their medical problems. No follow up visits are required as part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Radiofrequency ablation catheter (Habib EndoHBP)Radiofrequency ablation catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented malignant biliary obstruction requiring ERCP guided stenting
Key exclusion criteria (8 listed)
- Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
- Evidence of high-grade symptomatic duodenal obstruction
- Poor performance status
- Active suppurative cholangitis
- Complex stenoses will not be eligible for the trial
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 |
|---|---|---|
| Radiofrequency ablation catheter (Habib EndoHBP)Also: Habib EndoHBPCatheter placement into bile duct | Device | Treatment |
Primary outcome
Safety: Number of Bile Leak After RFA Procedure
Time frame: 2 years
Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)
2 secondary outcomes
Feasibility: Ease of the Radiofrequency Ablation Catheter Placement
Time frame: 2 years
Effectiveness: Change From Baseline in Bile Duct Diameter.
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study informationLink provided by the sponsor.
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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.
William R Brugge, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation catheter (Habib EndoHBP) in people with Obstruction of Biliary Tree and Biliary Tract Cancer, run by Massachusetts General Hospital at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 24 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety: Number of Bile Leak After RFA Procedure (time frame: 2 years). 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 24 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.