Biliary Tract Cancer, Biliary Tract Neoplasms, Obstruction of Biliary Tree
Conditions
Keywords
Bile duct, Cholangiocarcinoma, Bile duct stenosis, Malignant bile duct obstruction, Malignant bile duct stricture, Radiofrequency ablation, RFA, Endoscopic RFA catheter, EndoHPB
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.
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.
Interventions
DEVICERadiofrequency ablation catheter (Habib EndoHBP)
Catheter placement into bile duct
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Radiofrequency ablation catheter
Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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)
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Safety: Number of Bile Leak After RFA Procedure | 1 bile leak |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Effectiveness: Change From Baseline in Bile Duct Diameter. | 50 percentage of improvement: |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Feasibility: Ease of the Radiofrequency Ablation Catheter Placement | 10 units on a scale |