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Cholestasis clinical trials

View clinical trials related to Cholestasis.

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NCT ID: NCT00713427 Completed - Clinical trials for Biliary Strictures Caused by Malignant Neoplasms

Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Start date: July 2007
Phase: N/A
Study type: Interventional

This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

NCT ID: NCT00700232 Completed - Clinical trials for Intrahepatic Cholestasis of Pregnancy

ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

Start date: July 2006
Phase: N/A
Study type: Observational

Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy have not been clearly established. The aim of the present study is to describe the nature and frequency of these mutations in a series of patients with intrahepatic cholestasis of pregnancy and to compare with a control group of pregnant women without intrahepatic cholestasis of pregnancy.

NCT ID: NCT00685386 Completed - Cholestasis Clinical Trials

A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Start date: June 2008
Phase: N/A
Study type: Interventional

The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).

NCT ID: NCT00512629 Completed - Cholestasis Clinical Trials

Cholestasis Prevention: Efficacy of IV Fish Oil

Start date: July 2007
Phase: Phase 1
Study type: Interventional

Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury that may ultimately result in hepatic failure. In studies conducted in a murine model, we observed that intravenous fat emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of cholestasis, a common precursor of PN-associated liver disease, as well as reverse preexisting PNALD through a combination of factors, including improved triglyceride clearance coupled with anti-inflammatory properties. In a case series treating patients with hepatic cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no adverse reactions attributed to its use were observed. Based on results of these previous studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal failure

NCT ID: NCT00487201 Completed - Biliary Stricture Clinical Trials

Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement

Start date: April 2006
Phase: N/A
Study type: Interventional

Background and Study Aims: Biliary strictures are a major cause of morbidity following liver transplantation with an overall incidence between 10 and 30 %. Up to now biliary strictures were dilated subsequently one to three plastic stents with a diameter of eight to ten F were inserted. In general, stents were exchanged in two to three months intervals over one year. In the present prospective controlled study, efficacy and complication rates of balloon dilation have been compared with dilation plus stenting. Patients and Methods: XY patients with high-grade biliary strictures (anastomotic and non-anastomotic) were enrolled in this prospective study in random order. X patients were treated by endoscopic balloon dilatation and Y by balloon dilatation plus plastic stent placement in six to eight weeks intervals. The primary end point was permanent opening of the biliary obstruction of 12 months. Number of endoscopic interventions and complications of the procedures were monitored.

NCT ID: NCT00453076 Completed - Clinical trials for Bile Duct Obstruction

Paclitaxel Eluting Covered Metallic Stent for Unresectable Malignant Bile Duct Obstruction

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The primary goal is to determine stent patency and overall survival of the conventional covered self expandable metallic stent versus paclitaxel eluting covered self expandable metallic stent in unresectable malignant bile duct stricture. The secondary goals are to assess reinterventions, complications, technical difficulties, and physician graded ease of placement and to assess toxicity of paclitaxel eluting covered self expandable metallic stent.

NCT ID: NCT00433771 Completed - Clinical trials for Cholestasis, Extrahepatic

A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Start date: March 2007
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.

NCT ID: NCT00392977 Completed - Clinical trials for Necrotizing Enterocolitis

Brain Manganese Deposition in High Risk Neonates

Start date: August 2006
Phase: N/A
Study type: Observational

Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN solutions contain high concentrations of Mn. This proposal will investigate brain deposition of Mn, a paramagnetic element, by magnetic resonance (MR) imaging in preterm and term neonates receiving Mn-supplemented PN and gestational age-matched control infants. The goals of this project are to identify neonatal populations that are at increased risk of excessive brain Mn deposition based on their gestational age, iron status, hepatic function and dietary Mn intake, and to make evidence-based recommendations for appropriate Mn supplementation and monitoring of infants receiving PN.

NCT ID: NCT00392730 Completed - Clinical trials for Necrotizing Enterocolitis

Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children

Start date: August 2006
Phase: N/A
Study type: Observational

Manganese (Mn) is an essential metal required for normal growth and development. However, exposure to high Mn levels can be toxic to the brain. The objectives of this project are to identify neonatal and young pediatric populations that are at increased risk of excessive brain Mn deposition and altered cognitive and motor development based on their dietary parenteral Mn exposure, and to make sound and evidence-based recommendations for appropriate Mn supplementation and monitoring of infants and young children receiving parenteral nutrition (PN). Our studies are designed to test the hypotheses that, compared with unexposed age-matched controls, infants and young children receiving prolonged Mn-supplemented PN will have increased deposition of Mn in their brains and lower scores on neurodevelopmental, cognitive and psychophysiological assessments.

NCT ID: NCT00280709 Completed - Pancreatic Cancer Clinical Trials

Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction

Start date: January 2006
Phase: Phase 4
Study type: Interventional

The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.