View clinical trials related to Bile Duct Neoplasms.
Filter by:Successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. Surgical intervention for the sale is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time the quality of life following surgery is only improved in a minority. At present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. But this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic cells. This therapy involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. A randomized controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival. In photodynamic therapy (PDT) the uniform distribution of externally applied light is desirable but often difficult to achieve. An optical fiber tip producing cylindrical or lateral light emission can facilitate the application of laser energy by direct implantation of the tip into solid tumors. However, currently used FDA approved glass diffusers used in standard of care PDT might break in the bile ducts causing injury since they are not meant to be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need to evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser for photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer plastic optic diffuser is safe and effective in photodynamic therapy, it can be also used via a choledochoscope. We aim to add to the clinical evidence by conducting an open label observational study trial using this fiber optic diffuser during photo dynamic therapy in the bile ducts.
Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic device, which is designed to give a better flexibility to the cholangioscopy tip in order to enable optimal diagnostic and therapeutic precondition. Other than the conventional mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at the side of a specially developed duodenoscope (mother part) which is prepositioned distally to the control unit, near to the patient's mouth. Better manoeuverability of the device tip will lead to both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy manoeuvres. This study is designed to test the efficiency of the device in relation to this assumption.
This study is being done to determine the dose of a chemotherapy drug (irinotecan [irinotecan hydrochloride]) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs often used to treat gastrointestinal cancer, which consists of 5-FU (fluorouracil), leucovorin (leucovorin calcium), irinotecan and oxaliplatin and is known as "FOLFIRINOX". FOLFIRINOX is a current drug therapy combination (or regimen) used for people with advanced pancreatic cancer, although this combination is not Food and Drug Administration (FDA) approved for this indication. FOLFIRINOX was recently shown in a separate clinical trial to increase survival compared to another commonly used drug in pancreatic cancer called gemcitabine. FOLFIRINOX is also a reasonable regimen for those with other advanced cancers of the gastrointestinal tract, including colon cancer, rectal cancer, esophagus cancer, stomach cancer, gall bladder cancer, bile duct cancer, ampullary cancer, and cancers with an unknown primary location. The best dose of irinotecan to use in FOLFIRINOX is not known. This study will analyze one gene (uridine 5'-diphospho [UDP] glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] gene) of subjects for the presence of an alteration in that gene, which may affect how the body handles irinotecan. Genes help determine some of the investigators individual characteristics, such as eye color, height and skin tone. Genes may also determine why people get certain diseases and how medicines may affect them. The result of the genetic analysis will divide subjects into one of three groups: A, B, or C. Group A (approximately 45% of subjects) will receive the standard dose of irinotecan. Group B (approximately 45% of subjects) will receive a lower dose of irinotecan. Group C (approximately 10% of subjects) will receive an even lower dose of irinotecan
The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis. Bilateral drainage is more physiologic and have more long patency than unilateral drainage. There are two methods of bilateral drainage: Y-stent and side by side. However there are no clinical data about comparing the effectiveness of these two methods. Therefore the investigators want to compare the clinical outcomes of two methods: Y-stent and side by side.
This pilot clinical trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer. Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in patients receiving chemotherapy and radiation therapy
The purpose of this registry is to record information and evaluate the impact of Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided ERCP procedures have been assessed in a series of studies. This multi-center registry has been initiated: - To document the impact of EUS-Guided ERCP procedures on the management of pancreatico-biliary disorders including malignancies. - To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or therapeutic procedures. Design is retrospective and prospective registry study. Procedures that will be captured include: 1. EUS-Coils placement 2. EUS Glue injection 3. EUS-Fiducial placement 4. EUS-Neurolysis 5. EUS-Stent placement 6. EUS-alcohol injection 7. EUS-fluid collection, abscess or cavity drainage 8. EUS guided ductal drainage 9. EUS-guided Ablation 10. EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage
Strictures in the bile duct cause a blockage of flow of bile. This leads to potential problems including jaundice, itch and infection in the bile duct. The usual first step in this situation would be to allow flow of bile by placing a stent across the stricture. This is usually done by a special type of endoscopy procedure called an endoscopic retrograde cholangiopancreatography, or ERCP. The most commonly used stent are made from a plastic material called polyethylene and has a central lumen in which bile drains through it. Health Canada has approved the sale and use of another stent with a winged perimeter (the VIADUCT stent) for placement in bile duct strictures and is used routinely in our hospitals. However, the investigators do not know which stent is better at treating bile duct strictures. In order to determine which stent would be more useful, the VIADUCT stent and the usual polyethylene flanged stent must be studied under carefully controlled circumstances. This will be done by a randomized, subject-blinded study. Other trials in the past have looked at other stents in this way, but this is the first time the VIADUCT stent has been looked at in this manner. The investigators suspect that the design of the VIADUCT stent will allow it to work for a longer period of time compared to the traditional polyethylene stent.
Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.
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.