Primary Cholangioscopy Versus ERCP in the Diagnosis of Biliary Strictures

NCT04010734 | Unknown

• 1 other identifier: UHO001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Stricture

Keywords

suspected malignant biliary stricture; primary peroral cholangiscopy; endoscopic retrograde cholangiopancreatography; fluorescence in situ hybridization

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

peroral Cholangioscopy examination

ACTIVE COMPARATOR

Patient with suspected malignant biliary stricture (SMBS) is allowed: to the peroral Cholangioscopy examination with both visual and tissue diagnosis. The visual diagnosis is based on morphological and vascular patterns (presence or not of nodular or papilary masses, irregularity of the surface, morphology of the vessels and the fragility of mucosa). The tissue diagnosis consists on cytopathological evaluation after tissue sampling using minuature biopsy forceps (SpyBite). During this, 5-8 samples are taken under visual control, from different parts of the lesion.

Procedure: Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography

ERCP examination with sampling

ACTIVE COMPARATOR

Patient with suspected malignant biliary stricture (SMBS) is allowed: to ERCP examination with both sampling by brushing and forceps biopsy, with subsequent pathological evaluation and an additional fluorescence in situ hybridization(FISH) examination of the specimens. 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. Brushing and endocanal forceps biopsies were the most used techniques, both with different specificity and sensitivity. It was demonstrated that Fluorescence in Situ Hybridization (FISH) improved the diagnostic yield of routine cytology. That is the reason why the investigators will combine FISH with the sampling methods to maximize the chance to make early diagnosis of the biliary stenosis.

Procedure: Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography

Interventions

Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography PROCEDURE

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).

ERCP examination with sampling; peroral Cholangioscopy examination

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected malignant biliary stricture
• Localization: Extrahepatic biliary duct
• Patient´s consent with a diagnostic procedure
• Age : 18 years or more

You may not qualify if:

• Intrahepatic biliary strictures
• Duodenal stenosis (endoscopically)
• Age : \< 18 years
• Coagulopathy :
• (INR \>1,5, Platelets \< 100)
• Pregnancy

Sponsors & Collaborators

• University Hospital Olomouc: lead

Study Sites (1)

2nd Department of Internal Medicine, University Hospital and Palacký University, Olomouc, Czech Republic

Olomouc, Olomouc, 771 00, Czechia

RECRUITING

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Ondrej Urban, MD,pHD

  2nd Department of Internal Medicine, University Hospital Olomouc, Czech Republic

  STUDY CHAIR

Central Study Contacts

Vincent Zoundjiekpon, MD

CONTACT

00420608080209; vincent04@post.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: July 8, 2019
• Study Start: May 6, 2019
• Primary Completion: December 20, 2021
• Study Completion: June 7, 2022
• Last Updated: July 8, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)