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Jaundice, Obstructive clinical trials

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NCT ID: NCT06197984 Recruiting - Choledocholithiasis Clinical Trials

Antimicrobial Resistance in Acute Cholangitis

ARISE
Start date: January 8, 2024
Phase:
Study type: Observational [Patient Registry]

This study prospectively explores antimicrobial resistance in patients with acute cholangitis undergoing ERCP procedures. By analyzing patient profiles, microbial cultures, and treatment outcomes, the current study seeks to identify specific patterns of resistance, assess the effectiveness of current antimicrobial therapies, and explore potential strategies to optimize treatment regimens.

NCT ID: NCT06115655 Recruiting - Bile Duct Diseases Clinical Trials

A Single-center, Prospective Cohort Study on the Differentiation of Benign and Malignant Bile Duct Stenosis Based on Bile and Peripheral Blood cfDNA Methylation Profiles

Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to detect the methylation characteristics of cfDNA in the bile and plasma of patients with bile duct stricture. The main question it aims to answer is: Can the developed model, using peripheral blood and bile cell-free DNA sequencing, work well in screening and classifying unknown biliary stricture? Participants will collect approximately 10ml of peripheral blood and 5ml of bile from the patient.

NCT ID: NCT06115564 Recruiting - Choledocholithiasis Clinical Trials

Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"

Microbile
Start date: July 1, 2022
Phase:
Study type: Observational

The study is a prospective evaluation of the microbial assessment in patients undergoing to ERC with naive papilla; the population includes all the indication to biliary drainage.

NCT ID: NCT06106724 Recruiting - Clinical trials for Calcular Obstructive Jaundice

Primary Precutting Versus Conventional Over-the-Wire Sphinchterotomy For Managment Of Large Common Bile Duct Stones

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

During the last decades, endoscopic retrograde cholangiopancreatography (ERCP) has become the standard of care for the treatment of many pancreaticobiliary diseases [Canena et al., 2014]. However, ERCP is a challenging technique with a slow learning curve and is associated with complications, some of them lifethreatening [Chandrasekhara et al., 2017]. Post-ERCP pancreatitis (PEP) is the most common and serious complication after ERCP [Testoni et al., 2016]. A systematic survey of prospective studies including 16,885 patients reported an incidence of PEP of approximately 3.5%. Severe pancreatitis was found in 11% of the cases, and death occurred in 3% of PEP cases [Andriulli et al., 2007]. Therefore, many attempts to reduce the rate of this complication have been pursued. Selective cannulation of the common bile duct (CBD) is still considered to be a prerequisite for biliary sphincterotomy. Despite the use of various endoscopic retrograde cholangiopancreatography (ERCP) catheters and wire-guided sphincterotomes, CBD cannulation has been reported to fail in 5 % - 20 % of cases [Larkin and Huibregtse, 2001]. Precut sphincterotomy can allow access to the bile duct in such cases and is widely performed by expert endoscopists when there is a clear indication for endoscopic intervention. However, the use of precut sphincterotomy remains controversial because reported complication rates of the widely practiced needle-knife sphincterotomy (NKS) technique vary between 5 % and 20 % [Shakoor and Geenen, 1992]. Precut sphincterotomy, which includes needle-knife papillotomy (NKP), septotomy, and needle-knife fistulotomy (NKF), is often performed to facilitate access to the common bile duct of patients with difficult biliary access (DBA). Furthermore, NKF has been recommended as the preferred technique for precutting by the European Society of Gastrointestinal Endoscopy [Testoni et al., 2016] and the latest International Consensus[Liao et al., 2017]. The success of NKS also depends on the expertise of the endoscopist, and the consensus opinion is that this technique should only be performed by experienced endoscopists [Baillie,1997 ]. In contrast to NKS, incision of the papilla of Vater using an Erlangen-type precut sphincterotome has been previously reported by Binmoeller et al group to be an effective and safe auxiliary method for achieving access to the CBD after failed cannulation attempts [Binmoeller et al., 1996]. The definition of DBA varied widely [Mariani et al., 2016]. The latest guidelines for the definition of DBA differed widely from the latest guideline of The European Society of Gastrointestinal Endoscopy (defining DBA as the presence of ≥1 of the following: >5 contacts with the papilla while attempting to cannulate; >5 minutes spent attempting to cannulate following visualization of the papilla; >1 2 unintended pancreatic duct cannulation or opacification) [Testoni et al., 2016]. and the International Consensus Panel (defining DBA as the inability to achieve selective biliary cannulation by the standard ERCP technique within 10 minutes or up to 5 attempts or failure of access to the major papilla) [Liao et al., 2017 ].

NCT ID: NCT05979233 Recruiting - Clinical trials for Gall Bladder Disease

One Session Vs Staged Management of Calcular Obstructive Jaundice

Start date: August 5, 2023
Phase: N/A
Study type: Interventional

to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management

NCT ID: NCT05928286 Recruiting - Clinical trials for Obstructive Jaundice

Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice

Start date: December 1, 2022
Phase:
Study type: Observational

Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.

NCT ID: NCT05246176 Recruiting - Clinical trials for Obstructive Jaundice

Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Obstructive jaundice may be of malignant and benign etiologies. Carcinoma of the gall bladder, cholangiocarcinoma, pancreatic adenocarcinoma, metastasis, and lymph nodal compression of common bile duct (CBD) constitute the majority of malignant causes. Most of the patients with malignant obstructive jaundice are already advanced and inoperable by the time they are diagnosed, hence carry bad prognosis with palliation being the only option left. Obstruction needs to be drained even in such cases for reducing pain, cholangitis, anorexia and pruritus as well as to reduce the serum bilirubin levels in certain cases to initiate chemo or intrabiliary brachytherapy. Over the years, palliation has evolved with the introduction of newer methods and improvisation of existing techniques. Recent palliative measures prolong longevity and improve the quality of life, hence increasing the acceptance to such procedures; Methods of biliary drainage include: a. Surgical bypass b. Minimally invasive procedures; Endoscopic retrograde (ERCP) (cholangiopancreatography (ERCP), and Percutaneous transhepatic biliary drainage (PTBD). ERCP as well as PTBD are well-established and effective means for biliary drainage as palliative treatment in unresectable cases. With the current modern technique in experienced hands, Percutaneous Transhepatic Biliary Drainage (PTBD) equals endoscopic retrograde cholangio pancreatography (ERCP) regarding technical success and complications. In addition, there is a reduction in immediate procedure-related mortality with proven survival benefit. Moreover, it is the only immediate lifesaving procedure in cholangitis and sepsis.

NCT ID: NCT04801914 Recruiting - Clinical trials for Matrix Metalloproteinase

Enzyme Activity of Matrix Metalloproteinases in the Serum of Patients With Malignant Obstructive Hyperbilirubinemia Before and After PTBD

Start date: December 11, 2020
Phase:
Study type: Observational

The purpose of this study is to detect differences in the enzymatic activity of matrix metalloproteinases in patients with malignant obstructive hyperbilirubinemia before and after percutaneous biliary drainage.

NCT ID: NCT04801238 Recruiting - Pancreatitis Clinical Trials

preGallstep - A Clinical Pilot Trial

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

NCT ID: NCT04620577 Recruiting - Clinical trials for The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice

The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice

Start date: October 20, 2020
Phase:
Study type: Observational

To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.