Endoscopic Therapy of Malignant Bile Duct Strictures
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Radiofrequency ablation catheter |
Device: Radiofrequency ablation catheter (Habib EndoHBP)
Catheter placement into bile duct
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety: Number of Bile Leak After RFA Procedure [2 years]
Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)
Secondary Outcome Measures
- Feasibility: Ease of the Radiofrequency Ablation Catheter Placement [2 years]
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.
- Effectiveness: Change From Baseline in Bile Duct Diameter. [2 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Documented malignant biliary obstruction requiring ERCP guided stenting
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: William R Brugge, M.D., Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 11-405
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct |
| Period Title: Overall Study | |
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct |
| Overall Participants | 1 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
1
100%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1
100%
|
| Male |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
1
100%
|
Outcome Measures
| Title | Safety: Number of Bile Leak After RFA Procedure |
|---|---|
| Description | Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography) |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct |
| Measure Participants | 1 |
| Number [bile leak] |
1
|
| Title | Feasibility: Ease of the Radiofrequency Ablation Catheter Placement |
|---|---|
| Description | 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. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct |
| Measure Participants | 1 |
| Number [units on a scale] |
10
|
| Title | Effectiveness: Change From Baseline in Bile Duct Diameter. |
|---|---|
| Description | 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. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct |
| Measure Participants | 1 |
| Number [percentage of improvement:] |
50
|
Adverse Events
| Time Frame | 2 years. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Treatment | |
| Arm/Group Description | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct | |
All Cause Mortality |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | William R. Brugge |
|---|---|
| Organization | Mass. General Hospital |
| Phone | 617-724-0578 |
| wbrugge@partners.org |
- 11-405