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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03115411 -
Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction
|
N/A | |
Completed |
NCT02041390 -
Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases
|
N/A | |
Recruiting |
NCT01439698 -
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
|
N/A | |
Terminated |
NCT01413386 -
Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent
|
N/A | |
Completed |
NCT01543256 -
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
|
N/A | |
Enrolling by invitation |
NCT04572711 -
Prospective Evaluation of Biliary Tissue Sampling With ERCP
|
||
Recruiting |
NCT03229655 -
Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation
|
N/A | |
Completed |
NCT02916199 -
Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method
|
N/A | |
Recruiting |
NCT01522573 -
T-EUS for Gastrointestinal Disorders: A Multicenter Registry
|
N/A | |
Recruiting |
NCT01524146 -
Photodynamic Therapy (PDT) Cholangiocarcinoma Registry
|
N/A | |
Completed |
NCT02281019 -
SpyGlass AMEA Registry
|
||
Not yet recruiting |
NCT06369896 -
Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures
|
||
Recruiting |
NCT04391153 -
FISH in Diagnosis of Biliary Stricture
|
N/A | |
Active, not recruiting |
NCT03997994 -
DIGEST I Drug Coated Balloon for Biliary Stricture
|
N/A | |
Enrolling by invitation |
NCT03951324 -
Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
|
||
Unknown status |
NCT01085747 -
Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis
|
N/A | |
Completed |
NCT02105181 -
Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures
|
N/A | |
Recruiting |
NCT05761483 -
Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.
|
||
Completed |
NCT03673033 -
Biliary Complications in Live Donor Liver Transplantation
|
||
Recruiting |
NCT06277531 -
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)
|