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Cholestasis clinical trials

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NCT ID: NCT06385860 Not yet recruiting - Obesity Clinical Trials

Prediction Model for Early Biliary Stasis After Bariatric Surgery

PM-EBS-BS
Start date: July 2024
Phase:
Study type: Observational

Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery

NCT ID: NCT06369896 Not yet recruiting - Cholangiocarcinoma Clinical Trials

Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures

Spy+IDUS
Start date: May 5, 2024
Phase:
Study type: Observational

This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.

NCT ID: NCT06366880 Recruiting - Clinical trials for Cholestasis in Newborn

Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants. The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice. The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants.

NCT ID: NCT06366659 Not yet recruiting - Clinical trials for Intrahepatic Cholestasis of Pregnancy

Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy

Start date: April 20, 2024
Phase:
Study type: Observational

This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP.

NCT ID: NCT06364969 Not yet recruiting - Cholestasis Clinical Trials

Investigation of the Pruritogens of Liver-related Diseases

Start date: April 20, 2024
Phase:
Study type: Observational

This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP). In this study, a combination of skin application and needle-free subcutaneous injection was used to investigate whether human endogenous molecules can cause itching. And a questionnaire is used to quantify the intensity of different candidates-induced itch.

NCT ID: NCT06277531 Recruiting - Pancreas Cancer Clinical Trials

Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)

ECCBILE
Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures. Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%. In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.

NCT ID: NCT06183242 Recruiting - Clinical trials for Cholestasis, Intrahepatic

Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis

Start date: May 27, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic diffuse liver disease implies liver damage of various origin - viral hepatitis, the effect of xenobiotics (alcohol, drugs, medications, industrial toxins), metabolic disorders, non-alcoholic fatty liver disease. Intrahepatic cholestasis syndrome, or bile retention, occurs in 11-55% of cases of diffuse chronic liver diseases, usually leads to a worsening of the liver disease, a decrease in the effectiveness of treatment. The drug REMAXOL® is a solution for infusion, which has shown high effectiveness in the syndrome of intrahepatic cholestasis in cases of liver dysfunction due to acute or chronic damage. The study drug REMAXA® enteric-coated tablets is a hybrid drug which contains the same active metabolites as REMAXOL, i.e. inosine, methionine, nicotinamide, and succinic acid. The purpose of this study is to select the optimal dose and dosage regimen followed by evaluation safety and efficacy of REMAXA®, enteric-coated tablets, in comparison with REMAXOL®, solution for infusion, in patients who suffer from chronic diffuse liver diseases and have intrahepatic cholestasis.

NCT ID: NCT06170632 Not yet recruiting - Bile Duct Diseases Clinical Trials

Flare Type Self-expandable Metal Stents (SEMS) vs Plastic Stent for the Treatment of Difficult Common Bile Duct Stone

TEMASTI
Start date: March 2024
Phase: N/A
Study type: Interventional

Migration of stones from the gallbladder to the common bile duct (CBD) facilitated by gallbladder contractions can be listed as a complication of gallstones disease. In the case of common bile duct stone (CBDs) migration, an endoscopic cholangiopancreatography (ERCP) should be offered for both symptomatic and asymptomatic patients fit for the procedure. An ERCP with an adequate endoscopic sphincterotomy obtains a complete biliary clearance in about 80-90% of the patients[5]. Whilst most cases are successfully treated with such first-line approaches, about 10-15% need alternative and/or adjunctive techniques to achieve bile duct clearance. These conditions are generally defined as "difficult" bile duct stones, a broad category of cases that encompasses very different scenarios. In the case of irretrievable CBDs, the European Society of Gastrointestinal Endoscopy (ESGE) recommends the endoscopic placement of a temporary biliary plastic stent to warrant biliary drainage. Since their introduction, fully covered self-expanding metal stents (FCSEMS) have rapidly been adopted for the treatment of benign biliary conditions such as strictures, leaks, or bleeding. In a recent retrospective study it has been shown that FCSEMS are useful in the approach of difficult lithiasis of CBD with no significant adverse events associated. Moreover, a promising FC-SEMS with a particular prosthesis design (flare type - Niti-S "S-Type" Taewoong) could be even more useful since it reduces the frequent complication of fully covered stents which is the migration of the prosthesis. However, prospective data on the effectiveness and on the adverse events rate on the use of SEMS for incomplete stone CBDs clearance are still lacking. Therefore, the investigators aim to estimate the incidence of adverse events, complete biliary clearance, and migration rate after 3-6 month from ERCP index (stent positioning), comparing plastic stents vs FC-SEMS (Niti-S "flare type" - Taewoong).

NCT ID: NCT06048211 Not yet recruiting - Clinical trials for Neonatal Cholestasis

Impact of the Stool Color Scale on the Detection of Neonatal Cholestasis

Start date: September 10, 2023
Phase:
Study type: Observational

The stool color scale was set in 2018 in the health books of French children. The study aim is to see if the scale is usefull for healthcare professionals and if this scale has advanced the detection of neonatal cholestasis.

NCT ID: NCT06005701 Active, not recruiting - Clinical trials for Patient Satisfaction

Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

To predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.