Neoplasms

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Cholangiocarcinoma

Urinary Bladder Neoplasms

Lymphadenopathy

Gallbladder Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Lymphatic Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Bile Duct Cancer

Gallbladder Cancer

the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)

the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)

to use a LCD stent at an unilateral or bilateral stent insertion

stent insertion

to use ERCP for a stent insertion in an obstructive biliary tract

Endoscopic retrograde cholangiopancreatoscopy(ERCP)

Kwang hyuck Lee, PhD

Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.

Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.

There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.

Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent

Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent

Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent

Participants will followed after stent insertion and observe a complication rate between two groups.

Participants will followed for the new obstruction(new jaundice) will occur.

Kwang Hyuck Lee

Professor

Symptoms and General Pathology

Constriction, Pathologic

Cholestasis

Pathological Conditions, Anatomical

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
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent	NCT01875549	Obstruction of ... Cholangiocarcin... Hepatocellular ... Malignant Lymph... Gall Bladder Ca...	stent insertion Endoscopic retr...	18 Years -	Samsung Medical Center
Endoscopic Therapy of Malignant Bile Duct Strictures	NCT01543607	Obstruction of ... Biliary Tract C... Biliary Tract N...	Radiofrequency ...	18 Years -	Massachusetts General Hospital
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent	NCT01875549	Obstruction of ... Cholangiocarcin... Hepatocellular ... Malignant Lymph... Gall Bladder Ca...	stent insertion Endoscopic retr...	18 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for obstruction of biliary tree