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The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.
Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.
The purpose of this registry is to record information and evaluate the impact of radiofrequency ablation (RFA) of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders.
The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA for Pancreatico-biliary disorders | Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radio Frequency ablation Probe | Device | Any probe that can conduct radiofrequency ablation within biliary ducts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Bile Duct Stricture Diameter. | Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter. | 4 years |
| Number of Participants with Adverse Events | Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days of survival post intervention | Documentation of response rates,overall survival duration and overall stent occlusion-free duration. | 4 years |
| Number of overall stent occlusion-free days post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects over the age of 18 and suffering from pancreaticobiliary disorders, including malignancies such as Cholangiocarcinoma and Pancreatic Cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel Kahaleh, MD | Contact | 646-962-4000 | mik9071@med.cornell.edu | |
| Monica R Gaidhane, MD, MPH | Contact | 646-962-4796 | mog2012@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michel Kahaleh, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25033929 | Result | Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18. |
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No IPD Sharing
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Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.
| 4 years |
| Weill Cornell Medical College | Recruiting | New York | New York | 10021 | United States |
|
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D010190 | Pancreatic Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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