View clinical trials related to Cholestasis.
Filter by:Patients with gallstone disease should be checked whether a common bile duct (CBD) stone could be present. In case of a certain suspicion for CBD stones further investigations should be performed. This can either be done by magnetic resonance cholangio-pancreaticography (MRCP) or by intraoperative cholangiography. The study investigates which pathway would be favorable in regard of an early hospital demission.
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.
1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer. 2. Given the small size of the bile duct orifice and its close proximity to the pancreatic duct, selective biliary cannulation is the most difficult part of the endoscopic retrograde cholangiography (ERCP). 3. New small diameter sphincteromes and "short wire" systems (which allow physicians to control guidewires) offer potential, though untested advantages. 4. At most hosptial both the long and short wire systems as well as small versus standard are routinely used for clinical care. 5. Our hypothesis is that small diameter, physician controlled wires favor biliary cannulation 6. Our objective will be to assess whether small diameter sphincterotomes and "short wire" physician controlled guidewire cannulation favors successful bile duct cannulation and minimize complications.
Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been used as a principle palliative method of distal biliary obstruction in patients with pancreaticobiliary cancers. With potentially curative surgical resection being impossible, the maintenance of successful biliary drainage through patent stent has been regarded as the key to improve the quality of life and survival of patient, because it could prevent biliary infection or liver failure, and give patients opportunities for anti-cancer chemotherapy and/or radiotherapy. Although SEMSs have been reported to be superior to large bore plastic stents in terms of stent patency, they still have some controversial issues to resolve in relation to stent dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs, despite some clinical results of randomized trials favor to covered SEMSs. From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting results have been produced. It was initially assumed that covered SEMSs could cause the higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct and cystic duct by covering materials. However, no significant difference was found with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered SEMSs in several randomized trials and meta-analysis. The aim of the current study is to compare the cumulative stent patency of partially covered and uncovered SEMS as a primary objective, and investigate overall patient survival, stent dysfunction-free patient survival, and incidence of adverse events including stent dysfunction as secondary objectives.
The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment measure of itching) prior to the analysis of longitudinal treatment effect data being generated in ongoing clinical trials.
Although endoscopic retrograde cholangiopancreatography (ERCP) is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients. Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery. Up to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.
Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed. The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.
Although ERCP is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients. Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery. Up to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.10-21 There has been no comparative study between the outcomes of PTBD and EUS-BD focusing on the QOL, cost-effectiveness, and complications. The researchers investigated the technical success of EUS-BD and PTBD in patients with malignant biliary obstruction after failed conventional ERCP as a prospective randomized comparative study in multicenters. Secondary endpoints were the cost-effectiveness and complications rates between EUS-BD and PTBD.
This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX). Efficacy will be assessed by evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus associated with PFIC.
The purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at RedPATH. In some patients additional brushings will be obtained for FISH testing (this adds <2 minutes to ERCP and only associated risk is increased procedure duration). The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity and accuracy when compared to cytology +FISH in patients with biliary strictures. Primary aim: To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. Secondary aims: 1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used. 2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.