Primary Peroral Cholangioscopy Versus Endoscopic Retrograde Cholangiopancreatography (With Conventional Sampling - Brushing and Forceps Biopsy- Completed by Fluorescence In Situ Hybridization) in the Diagnosis of Biliary Strictures
Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography
Diagnostic Study
Summary
Study start date: May 6, 2019
Actual date on which the first participant was enrolled.The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Biliary strictures have various etiologies (traumatic, inflammatory, tumoral, ischemic etc), which are necessarily needed to be known for the correct therapeutic approach. Despite the emerging multitudes of new diagnostic opportunities and modalities (laboratory, radiological, endoscopic, histopathologic and immunohistological) which exist today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The dilemma that exists is how to balance the risk of missing the chance of curative surgery for some malignancy and preventing some patients from unnecessary surgery for benign etiologies and not to waste time. Therefore, diagnostic methods which can maximize the chance of the preoperative diagnosis of indeterminate biliary strictures are needed. This study will: compare two methods helping in the diagnosis of suspected malignant biliary stricture-SMBS evaluate the impact of both methods on the management of patients with biliary strictures. * ERCP (Endoscopic retrograde cholangiopancreatography) is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Different methods were used to take samples from the site of the stenosis. Brush-cytology and endocanal forceps biopsies were the most used techniques, both with differents specificity a sensitivity. It was demonstrated by different studies, that Fluorescence in Situ Hybridization (FISH) improved the diagnostic yield of routine cytology. That is the reason why the investigators are going to combine FISH with the conventional sampling methods to maximize the chance to determine the etiology of stenosis early and avoid wasting time. * The peroral cholangioscopy (DSOC), one of a newer method of endocanal exploration via ERCP- commonly known as the SpyGlass - helps to provide the visual diagnostics of the strictures based on morphological and vascular patterns and to provide directed intraductal biopsy (SpyBite) from the lesions. The combination of both methods should increase the diagnostic yield in the evaluation of indeterminate biliary stricture by DSOC. Because of its high costs, the DSOC is mostly provided later, that is when the ERCP cytology failed (secondary DSOC). This wasted time can be important and determinable for the patients´ outcome. So primary cholangioscopy could help in the correct management of patients with indeterminate biliary stricture, without wasting time. The study will compare the primary DSOC to ERCP. Success (positivity) is defined by the presence of benign or malignant cells, adequate to make the final tissue diagnosis. Another examination should be performed in situations where the initial method failed. Gold standard for final diagnosis should be the histology from surgery resection. In patients without surgery, clinical evaluation and cross-over methods are used for comparison of initial methods.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.66 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 95 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Suspected malignant biliary stricture 2. Localization: Extrahepatic biliary duct 3. Patient´s consent with a diagnostic procedure 4. Age : 18 years or more Exclusion Criteria: 1. Intrahepatic biliary strictures 2. Duodenal stenosis (endoscopically) 3. Age : \< 18 years 4. Coagulopathy : (INR \>1,5, Platelets \< 100) 5. Pregnancy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
2nd Department of Internal Medicine, University Hospital and Palacký University, Olomouc, Czech Republic
Olomouc, CzechiaOpen 2nd Department of Internal Medicine, University Hospital and Palacký University, Olomouc, Czech Republic in Google Maps