Primary Cholangioscopy Versus ERCP in the Diagnosis of Biliary Strictures

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04010734
• Other study ID #: UHO001
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: June 7, 2022

Study information

• Verified date: June 2019
• Source: University Hospital Olomouc
• Contact: Vincent Zoundjiekpon, MD
• Phone: 00420608080209
• Email: vincent04[@]post.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Biliary Stricture
• Cholestasis
• Constriction, Pathologic

Intervention

Procedure:
• Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography
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 should increase the diagnostic yield in the evaluation of indeterminate biliary stricture by DSOC. ERCP 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. Brushing and endocanal forceps biopsies were the most used techniques. The samples from these two techniques will be additionaly examinated using Fluorescence in Situ Hybridization (FISH).

Locations

Country	Name	City	State
Czechia	2nd Department of Internal Medicine, University Hospital and Palacký University, Olomouc, Czech Republic	Olomouc 1	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

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