Endoscopic Therapy of Malignant Bile Duct Strictures
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | February 2012 |
| End Date: | June 2014 |
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 catheter is in patient with malignant bile duct stenosis.
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 catheter is in patient with malignant bile duct stenosis.
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.
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.
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
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