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Cholestasis clinical trials

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NCT ID: NCT03387579 Completed - Clinical trials for Cholestasis of Parenteral Nutrition

Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

Start date: November 30, 2018
Phase: Phase 3
Study type: Interventional

Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.

NCT ID: NCT03358095 Withdrawn - Pancreatic Cancer Clinical Trials

Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?

Start date: November 26, 2017
Phase: N/A
Study type: Interventional

Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.

NCT ID: NCT03353454 Withdrawn - Clinical trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

Start date: October 25, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).

NCT ID: NCT03337074 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Paternally Inherited Phenotypes in Cholestasis

PIP-C
Start date: February 8, 2017
Phase:
Study type: Observational

For some years investigators have known that the health of fathers at the time their baby is conceived has an influence on the health of their child in the future. Many studies looking at this effect have investigated fathers with obesity and other metabolic disorders. These disorders can alter the risk of obesity and diabetes in the children of these men. More recently, studies have been undertaken to establish the mechanism by which this risk is inherited by the children. Studies of sperm have identified that changes in the structure and function of the sperm play a role. Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cholangitis (PBC) are included in a group of cholestatic liver disorders that are associated with elevated levels of bile acids in the blood (cholestasis). A previous study has established that children born to women who have cholestasis during pregnancy are at an increased risk of obesity later in life. Our study will investigate whether there is a similar effect on the health of children if their father has cholestasis. The study has 2 arms, the Sperm Epigenome arm and the Outcomes arm. In the Sperm Epigenome arm of the study, the structure and function of sperm from men with PSC, PBC and other cholestatic liver disorders will be investigated and compared to the structure and function of sperm from healthy men. In the Outcomes arm of the study, basic health parameters of fathers who had PSC, PBC or another cholestatic liver disease either before or after their child was conceived will be studied. Basic health parameters will also be studied in their child when the child is between 16 and 25 years of age.

NCT ID: NCT03307382 Recruiting - Biliary Stricture Clinical Trials

Single-operator Digital Cholangioscopy for the Diagnosis of Malignant and Benign Biliary Strictures

Start date: December 15, 2015
Phase: N/A
Study type: Interventional

Differentiation between malignant and benign biliary strictures can be challenging. Accurate differentiation of malignant biliary strictures from benign ones is crucial to guide management decisions. While conventional tissue acquisition techniques such as brush cytology or intraductal biopsy of the biliary stricture is often performed during ERCP for tissue diagnosis, their sensitivities are suboptimal. The average sensitivities for brush cytology and intraductal biopsy were reported to be ~ 59% and ~ 63% respectively. When the cause of a biliary stricture remains unclear despite conventional ERCP techniques for diagnosis, cholangioscopy is often performed during ERCP to clarify the diagnosis. This allows an endoscopist to obtain a visual impression (VI) and to perform targeted biopsy under direct visualization of the biliary stricture. Recently, a digital SOC system (SpyGlass Digital System (SpyGlass DS), Boston Scientific, USA) has become available and has the potential to further improve the diagnosis of malignant and benign biliary strictures. The utility of this digital SOC in the evaluation of biliary strictures has not been well studied. We propose this study to evaluate the utility of the digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.

NCT ID: NCT03279809 Terminated - Clinical trials for Biliary Stasis, Extrahepatic

The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction

Start date: October 12, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to determine whether administration of aspirin can help maintain the patency of metallic stents for distal malignant common bile duct obstruction. Metal stents are mainly used for malignant biliary obstruction if the surgical treatment is not considered and its maintenance period has been reported to be about 8 months. This study will be prospectively conducted as a randomized controlled study with aspirin treated patients who received metal stents in patients over 20 years who were confirmed malignant distal biliary obstruction. The primary endpoint is the incidence of stent dysfunction in both groups for 6 months after the procedure. The secondary endpoints included duration of metallic stent patency, incidence of further procedures, and adverse events related with aspirin.

NCT ID: NCT03237247 Completed - Clinical trials for Extrahepatic Cholestasis

Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis

Start date: March 1, 2016
Phase: N/A
Study type: Observational

Cases with extrahepatic cholestasis are common and faced during day to day clinical practice, however reaching the final etiology is sometimes challenging and needs investigations which are usually expensive, may carry hazards to the patients, or inaccessible so we are in need for a method which is easily available, affordable and safe for aiding in the differential diagnosis of extrahepatic cholestasis. our study aiming to evaluate the role of complete blood count in predicting the etiology of extrahepatic cholestasis.

NCT ID: NCT03229655 Recruiting - Biliary Stricture Clinical Trials

Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation.

NCT ID: NCT03140007 Not yet recruiting - Cholangiocarcinoma Clinical Trials

Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic .

Cholangioscopy
Start date: June 15, 2017
Phase: N/A
Study type: Interventional

Primary Objective: To assess the diagnostic accuracy of cholangioscopy-based assessment using SpyDS technology compared to cholangiography-based assessment using ERCP-guided biopsy and brushing in patients with indeterminate biliary strictures in the setting of cholangiocarcinoma.

NCT ID: NCT03082937 Completed - Clinical trials for Primary Biliary Cirrhosis

An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects

Start date: January 31, 2017
Phase: Phase 1
Study type: Interventional

The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural identification in healthy male subjects.