Biliary Stricture Clinical Trial
Official title:
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
NCT number | NCT04010734 |
Other study ID # | UHO001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2019 |
Est. completion date | June 7, 2022 |
The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities and modalities which exist today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study´s aim is to compare the diagnostic yield of primary peroral cholangioscopy and ERCP (with conventional sampling - brushing and forceps biopsy - completed with the FISH) in patients with suspected malignant stricture of the common bile duct and to evaluate the impact of both methods on the management of patients with biliary stricture.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | June 7, 2022 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | 2nd Department of Internal Medicine, University Hospital and Palacký University, Olomouc, Czech Republic | Olomouc 1 | Olomouc |
Lead Sponsor | Collaborator |
---|---|
University Hospital Olomouc |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | compare the diagnostic yield of the primary peroral cholangioscopy and the ERCP in patients with suspected malignant biliary stricture - SMBS | The the sensitivity (%) and specificity (%) of primary Peroral Cholangioscopy and ERCP(with conventional tissue sampling completed with FISH) in patients with suspected malignant stricture of the common bile duct are evaluated. Success (positivity) is defined by the presence of benign or malignant cells, adequate to make the final tissue diagnosis. Based on the previous studies and the experiences of our endoscopists and pathologist, we can expect the diagnostic yield of primary SpyGlass around 92% and of the second method around 75% in the study population (the samples size 66). | 1-7 days | |
Primary | evaluate the impact of both methods on management of patients with biliary stricture. | The proportion of patients (%) who will miss the chance of curative surgery for some malignancy and the proportion of patients (%) who will not have unnecessary surgery for benign etiologies are evaluated in each group. | 3-6 months | |
Primary | evaluate the cost-effectiveness of both methods on management of patients with biliary stricture. | The ratio cost (USD)/diagnostic yield(%) of both methods is evaluated and compared. | 3-6 months |
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