Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Endoscopic Bipolar RadioFrequency Probe used to remove tumors in bile duct to manage Pancreatic Cancer

The purpose of this study is to determine whether the use of an FDA approved endoscopic bipolar catheter (EndoHPB) will ablate tissue in malignant tumors within the pancreatic ducts.

Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection. Therefore most patients with malignant biliary obstruction will need palliation of their jaundice to relieve the symptoms of pruritus, malabsorption, sepsis and to minimize potential hepatorenal complications. Restoring biliary flow with relief of jaundice is the primary goal in the palliation of obstructive biliary malignancy. Drainage at endoscopic retrograde cholangiopancreatography (ECRP) is established as a safer approach than at percutaneous transhepatic cholangiography (PTC) because it has a lower risk of bile leak, infection and hemorrhage. ECRP is the first approach to relieve malignant biliary obstruction but sometimes it is not technically possible to stent the patient by this approach, then a PTC needs to be undertaken. Self expanding mesh metal stents (SEMS) were introduced back in the 1990s. Problems can still arise with the use of covered stents such as cholecystitis, pancreatitis or tumor overgrowth at the end of the stent, and not all studies have shown that covered stents actually reduce the problems of tumor ingrowth and consequent stent occlusion. EndoHPB can be deployed via an ERCP or PTC route. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may may delay tumor growth and the time before the stent lumen becomes blocked. Thereby this allows increased periods between the need for intervention and further stent deployment. If EndoHPB use of luminal RF is demonstrated to be effective in luminal tumor ablation, it may have an additional role as a form of neoadjuvant therapy in cholangiocarcinoma and pancreatic cancer.

Radiofrequency Probe for Management of Unresectable Bile Duct and Pancreatic Cancer

Pilot Study to Assess Safety and Efficacy Of An Endoscopic Bipolar Radiofrequency Probe (EndoHPB) In the Management of Unresectable Bile Duct and Pancreatic Cancer

Ochsner Health System

Virendra Joshi, MD

Symptoms and General Pathology

Cholangiocarcinoma

Constriction, Pathologic

Cholestasis

Bile Duct Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pathological Conditions, Anatomical

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Bile Duct Cancer

Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies.

Any probe that can conduct radiofrequency ablation within biliary ducts.

Radio Frequency ablation Probe

Michel Kahaleh, MD

Monica R Gaidhane, MD, MPH

William R Brugge, MD

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:

1. To document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreaticobiliary disorders.
2. To assess the immediate and 6 months post procedure adverse event rate in patients.
3. To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.

Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.

Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.

Documentation of response rates,overall survival duration and overall stent occlusion-free duration.

Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.

Weill Medical College of Cornell University

Chief, Advanced Endoscopy

Biliary Tract Cancer

Radiofrequency ablation catheter (Habib EndoHBP)

William R Brugge, M.D.

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.

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.

Endoscopic Therapy of Malignant Bile Duct Strictures

Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study

Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)

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 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.

Massachusetts General Hospital

Principal Investigator

Radiofrequency ablation catheter

Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiofrequency Probe for Management of Unresectable Bile Duct and Pancreatic Cancer	NCT02042859	Pancreatic Canc...	Endoscopic Bipo...	18 Years -	Ochsner Health System
Radiofrequency Probe for Management of Unresectable Bile Duct and Pancreatic Cancer	NCT02042859	Pancreatic Canc...	Endoscopic Bipo...	18 Years -	Ochsner Health System
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry	NCT01439698	Cholangiocarcin... Pancreatic Canc... Bile Duct Cance... Biliary Strictu... Bile Duct Obstr...	Radio Frequency...	18 Years -	Weill Medical College of Cornell University
Endoscopic Therapy of Malignant Bile Duct Strictures	NCT01543607	Obstruction of ... Biliary Tract C... Biliary Tract N...	Radiofrequency ...	18 Years -	Massachusetts General Hospital
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry	NCT01439698	Cholangiocarcin... Pancreatic Canc... Bile Duct Cance... Biliary Strictu... Bile Duct Obstr...	Radio Frequency...	18 Years -	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for endohpb

Every month we try and update this database with for endohpb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for endohpb

Every month we try and update this database with for endohpb cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for endohpb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.