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Cholestasis clinical trials

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NCT ID: NCT01524146 Recruiting - Biliary Stricture Clinical Trials

Photodynamic Therapy (PDT) Cholangiocarcinoma Registry

PDTRegistry
Start date: November 2011
Phase: N/A
Study type: Observational

Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma in the United States. Several European studies have reported the efficacy and safety of Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported the same in the United States. The establishment of a registry to capture all PDT cases within and outside US can help the investigators evaluate a larger and non-ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of PDT for unresectable cholangiocarcinoma. With more endoscopists considering PDT as a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to further evaluate the efficacy and safety of such combined procedures as well. The ultimate objective is to assess if PDT with or without additional or adjuvant treatment options prolongs survival duration and improves quality of life in patients with unresectable cholangiocarcinoma. This multicenter registry has been initiated: - To document the impact of PDT on the clinical management of unresectable cholangiocarcinoma. - To assess the clinical and technical success rates of PDT for unresectable cholangiocarcinoma.

NCT ID: NCT01522573 Recruiting - Pancreatic Cancer Clinical Trials

T-EUS for Gastrointestinal Disorders: A Multicenter Registry

EUSERCPReg
Start date: November 2011
Phase: N/A
Study type: Observational

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

NCT ID: NCT01501474 Terminated - Clinical trials for Malignant Biliary Strictures

Utility of CholangioFlex and Fluorescent in Situ Hybridization in the Diagnosis of Malignant Biliary Strictures

Start date: January 2012
Phase:
Study type: Observational

Utility of CholangioFlex and Fluorescent in situ Hybridization in the Diagnosis of Malignant Biliary Strictures Objectives 1. To assess the sensitivity, specificity and accuracy of CholangioFlex in malignant biliary stricture diagnosis 2. To assess the sensitivity, specificity and accuracy of Fluorescent in situ Hybridization(FISH) in malignant biliary stricture diagnosis Study design One academic center, prospective, diagnostic study Research Methodology Target population: Patients who are diagnosed malignant biliary stricture. Sample population: Patients who are diagnosed malignant biliary stricture in Chulalongkorn Hospital

NCT ID: NCT01499524 Completed - Clinical trials for Gestational Diabetes Mellitus

The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus

Start date: November 2011
Phase:
Study type: Observational

ICP is known to cause abnormal bile acid homeostasis and to be associated with an increased risk of diseases of the biliary system in later life. There have been small studies (Dann et al. 2006; Wójcicka-JagodziƄska et al. 1989) suggesting that it causes dyslipidaemia (raised lipids) and impaired glucose tolerance in pregnancy. However the underlying mechanisms of these abnormalities is not known. Similarly the influence of cholestasis on fetal metabolism is not known, and nor is the role of the placenta. It is also not known whether women with ICP have a predisposition to abnormal lipid and glucose homeostasis when they are not pregnant. GDM is characterized by raised plasma glucose levels in pregnant women (in the absence of pre-pregnancy diabetes mellitus). This condition is associated with large-for-gestational age babies and obstructed labour. Women with GDM have increased risk of subsequent type 2 diabetes mellitus, and if they have this condition in a subsequent pregnancy there is an increased risk of stillbirth. This work is important to understand the causes of the metabolic abnormalities associated with ICP and GDM. If we demonstrate abnormal lipid and glucose profiles, these may be of relevance to the fetal complications of both disorders. It will also be of relevance to the future health of affected women and their children.

NCT ID: NCT01457105 Completed - Clinical trials for Malignant Biliary Strictures

Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent

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

self-expandable metal stents for palliation of malignant biliary strictures

NCT ID: NCT01457092 Completed - Clinical trials for Chronic Pancreatitis

Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis

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

The purpose of the study was to analyze the resolution rate of benign biliary strictures due to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully covered self-expandable metal stents.

NCT ID: NCT01439698 Recruiting - Pancreatic Cancer Clinical Trials

Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

RFA-Registry
Start date: September 2011
Phase: N/A
Study type: Observational [Patient Registry]

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.

NCT ID: NCT01439620 Completed - Biliary Stricture Clinical Trials

Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

Start date: February 2009
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the potential of comprehensive biliary Optical Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (PSC).

NCT ID: NCT01412359 Approved for marketing - Clinical trials for Total Parenteral Nutrition-induced Cholestasis

Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury

Start date: n/a
Phase:
Study type: Expanded Access

The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated cholestasis. It is a compassionate use protocol for patients who already have significant cholestasis related to parenteral nutrition.

NCT ID: NCT01383746 Terminated - Clinical trials for Cholestasis, Progressive Familial Intrahepatic 3

Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION

CHOLANGIOSIR
Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival < 3% at 5 years). Less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. It is not standard first-line chemotherapy validated for unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4 months). In case of tumor progression ater this first line therapy, no treatment is currently being validated. RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium microspheres. In the patients with unresectable CCK , the first pilot studies showed interesting results with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety. Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic CCK in tumor progression after first-line therapy.