View clinical trials related to Biliary Condition.
Filter by:Since its introduction more than 40 years ago, endoscopic retrograde cholangiopancreatography (ERCP) has fundamentally changed the treatment of biliopancreatic diseases. Since late 1970s there have been sporadic reports of nosocomial infections linked to endoscopic procedures, the majority caused by inadequate reprocessing of endoscopes. Infections due to multidrug-resistant organisms (MDROs) however have increasingly become a concern in health care, including in gastrointestinal (GI) endoscopy. Since 2010, reports of individual cases and serial outbreaks of MDRO infections associated with ERCP have been published worldwide. This is because, unlike a gastroscope or colonoscope, the duodenoscope is a complex instrument with unique mechanical features incorporated at the distal tip. This includes a recessed space containing an elevator, a wire cable that moves the elevator, working channel, and most recently, a seal that prevents contamination of the elevator wire channel. This complex design creates hard-to-reach areas that make optimal mechanical cleaning and disinfection difficult. With the aim of overcoming these issues, a single-use duodenoscope (EXALT Model D, Boston Scientific Corporation, Marlborough, Massachusetts, USA) has been developed in the United States of America (USA) and approved by the United States Food and Drug Administration (FDA) for clinical use in December 2019. Different studies evaluating this new device, including randomized clinical trials (RCTs), have already been published, which have confirmed that single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands. Digital Single Operator Cholangioscopy (D-SOC) using the single use Spyglass DS II (Boston Scientific Corporation, Marlborough, Massachusetts, USA) is a diagnostic and therapeutic modality which allows for direct endoscopic visualization of the biliopancreatic ductal system. The principal diagnostic indication of D-SOC are bile duct or pancreatic strictures and unclear filling defects, adding direct endoscopic appearance data to biopsy sampling or brush cytology in order to improve the diagnostic yield. The major therapeutic indication for D-SOC is lithotripsy for difficult biliary and pancreatic stones. However, cholangioscopy increased the risk of post ERCP cholangitis. Bacteremia was suggested to be specifically related to cholangioscopy in 13.9% of 72 patients, based on serial blood samplings, and to be associated with biopsy sampling and strictures. For this reason, the recent European Society of Gastrointestinal Endoscopy (ESGE) guideline suggests that patients should be considered to be at high risk for post-ERCP cholangitis when cholangioscopy is performed. Presently, there are very few clinical reports about technical and clinical outcome of ERCPs performed with single use duodenoscope and there is complete lack of data about efficacy, safety and adverse events of the combination of the new single-use duodenoscope and the Spyglass DS II. The aim of this multicentric retrospective study was to evaluate the technical success, clinical outcome and rate of adverse events of this procedure.
Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for many bilio-pancreatic diseases, and requires the first crucial step of the successful deep cannulation of the common bile duct through the Vater's papilla. Difficult biliary cannulation (DBC) is a well-recognized risk factor for adverse events (AE) and cannulation failure, which has been reported in about 11% of ERCP regardless of their indication and a relevant heterogeneity in definition of DBC is present in the available studies. More recently, DBC during ERCP has been precisely defined by the European Society of Gastrointestinal Endoscopy (ESGE) as follows: more than 5 contacts with the papilla whilst attempting to cannulate; more than 5 minutes spent attempting to cannulate after visualization of the papilla; more than one unintended pancreatic duct cannulation or opacification (4). To date, the rate of DBC has not been calculated for specific sub-groups of ERCP indications. In particular, the rate of DBC in the setting of distal malignant biliary obstruction (DMBO), a frequent indication for ERCP, has not yet been described. DMBO is generally secondary to pancreatic adenocarcinoma, distal cholangiocarcinoma, ampullary carcinomas or adenopathy/metastasis from other cancers, and could potentially increase the complexity of the procedure as the tumor compression or infiltration alter the normal duodenal/papillary anatomy or determine duodenal rigidity. In this study, we aimed to investigate the rate of DBC and the outcome of patients undergoing ERCP for DMBO.
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure used for the diagnosis and treatment of diseases of the biliary tract, pancreas and papilla of Vater. The ERCP allows an indirect vision of the ductal and pancreatic system by means of the endoductal injection of contrast medium and the evaluation of these by X-rays. Recently, cholangioscopy has been developed using the Spy Glass system, introduced on the market in 2007. This allows a direct visualization of the bile duct and pancreatic pathway through the introduction of an optical probe inside the ductal system. SpyGlass was developed to overcome the limitations of traditional cholangioscopy and allow optically guided therapies for the treatment of stenoses and calculations. This is the first cholangioscopy system performed by a single disposable operator (SOC), with two dedicated irrigation channels, an optical channel and a therapeutic channel with a diameter of 1.2 mm. Everything is placed inside a 10 Fr Spy Scope ™ access and delivery catheter (3.3 mm), which allows the tip to flex in 4 directions to facilitate maneuverability and directionality in small ducts. The irrigation channels of the SOC system allow a fluid flow rate of four to five times higher than that which can be obtained through the operating channel of conventional systems. In bench simulations with loaded Spy Bite ™ biopsy forceps, the SOC system presented a success rate in obtaining access to sites of double interest compared to that of a conventional 2-way limited bending choledocoscope. Some studies have confirmed the adequacy of the Spy Glass system in providing adequate samples for histological diagnosis and successfully facilitating the treatment of stones. The new single-use Spy Glass digital display system was introduced in 2014 and no multi-center experience on the use of this device is described to date.