View clinical trials related to Bile Duct Lesions.
Filter by:Digital single-operator cholangioscopy (DSOC) has emerged as a medical advance with an important role in the evaluation of indeterminate biliary lesions. This technique has demonstrated higher sensitivity in the guidance for tissue acquisition when compared with standard endoscopic retrograde cholangiopancreatography (ERCP). DSOC-guided biopsy is considered technically safe and successful for tissue collection. Hand in hand with the development of more precise diagnostic techniques, comes the implementation of artificial intelligence (AI) for diagnostic assessment. For the past decade, the role of artificial intelligence (AI) has been increasing at a rapid pace. In the biliary tract, different models have been proposed for the characterization of malignant features. Nevertheless, to date, the discrepancy between the visual impression of the operator and the histological results obtained by cholangioscopy still present, affecting the accuracy the diagnosis. Based on the above, the investigators aim to assess the diagnostic accuracy of AI for the guidance of tissue acquisition with DSOC compared to DSOC without AI for suspected cholangiocarcinoma. As a secondary aim, the investigators pursue to compare quality of AI-guided biopsies samples vs. DSOC biopsies without AI.
The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria. This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.
Endoscopic retrograde cholangio-pancreatography (ERCP) is a diagnostic and therapeutic procedure, however it has an important image limitation. The fluoroscopic cholangiography shows the biliary tree in a two-dimensional view. When an indeterminate biliary stricture is seen, the certainly diagnosis by ERCP depends on a blind biopsy sampling with the risk of missed pathology and sampling errors. SpyGlass® System (Boston Scientific, Marlborough, Massachusetts, USA) is a cholangioscope that enables single-operator, direct visualization of the pancreatico-biliary system and the evaluation of intraductal lesions. It has a digital sensor with 4x resolution and a 1.2 mm working channel that allows the passage of the SpyBite® Forceps biopsy. It has been demonstrated that the use of SpyGlass® System and SpyBite® Forceps changes clinical management in 64% of patients. It has a sensitivity of 76.5% for indeterminate stricture diagnosis, compared to 29.4% and 5.9% sensitivity using blind biopsy brushing catheter respectively. Although it has been described before cholangioscopic images of malignant biliary lesions like an irregular lesion surface with irregular vessels and bleeding or a smooth surface without vessels for benign lesions, there is no current validated classification that allows unify the diagnostic criteria. Methods: Study design: The study was design to be performed in 2 stages. Stage 1: observational, retrospective study with case collection from September 2013 to September 2015. Patients included had bile duct tissular lesion detected by POCS. The images were correlated to histopathology and 6 month follows up and a classification was finally performed to differentiate benign forma malignant bile duct lesions. Stage 2: patients with bile duct tissular lesion detected by POCS, will be the evaluated in a prospective, non-randomized and double blind manner. Two groups of endoscopist will evaluate the images but only one group will do it using the classification previously performed. Second stage case collection has already started (December 2015) and will include patients until December 2016. - Endpoint Classification: Efficacy - Intervention Model: Non interventional - Primary Purpose: Diagnosis