Symptoms and General Pathology

All Conditions

Constriction, Pathologic

Pathological Conditions, Anatomical

Lewis R Roberts, MB, ChB, PhD

Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a prospective study in 2 university hospitals to determine diagnostic performance of FISH for the diagnosis of malignant biliary strictures in Thai patients.

Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators aimed to compare the sensitivity of FISH and conventional cytology for the diagnosis of malignant biliary strictures in Thai patients. A prospective study was performed in 2 university hospitals between 2010 and 2013. Patients being evaluated for malignant-appearing biliary strictures were included. Bile duct brushings were collected and assessed by cytology and FISH. Sensitivities with 95% confidence intervals of cytology and FISH were main outcome measurements.

Brush samples obtained from endoscopic retrograde cholangiopancreatography

Performance of FISH for the Diagnosis of Malignant Biliary Strictures in Thai Patients

Fluorescence in Situ Hybridization (FISH) Improves Performance of Conventional Cytology for the Diagnosis of Malignant Biliary Tract Strictures in Thai Patients

Sensitivities with 95% confidence intervals of FISH and routine cytology will be compared

Chulalongkorn University

Mayo Clinic

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Pancreatic Neoplasms

Adenoma

Cholangitis

Cholestasis

Bile Duct Diseases

Cholangitis, Sclerosing

Bile Duct Neoplasms

Adenoma, Bile Duct

Papilloma, Intraductal

Cholestasis, Extrahepatic

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Neoplasms

Pancreatic Cancer

Bile Duct Cancer

Primary Sclerosing Cholangitis

Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures

Experienced Endoscopists with non-significant or beignner user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures

Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures

Interobserver agreement or Interrater agreement

Michel Kahaleh, MD

The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria.

This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.

Objective: Validate diagnostic impact of VLE diagnostic accuracy on clinical management

Primary Objectives:

1. Interobserver study for criteria validation and accuracy, Positive predictive value (PPV) and Negative predictive value (NPV), sensitivity and specificity.
2. Evaluation of VLE diagnostics on clinical management (increased accuracy/faster detection)
3. Determination of learning curve to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management.

B. Hypotheses / Research Question(s) The new VLE criteria for biliary and pancreatic duct strictures increase accuracy, thus leading to substantial impact on clinical management (Screening and Treatment)

Study Design (2 phase):

* Phase 1: Primary Objective 1 and 2 part of the study will be completed.
* Phase 2: Primary Objective 3 of the study will be conducted within 1 month.

Study Timeline: 3 months post WIRB approval. Sample size: 40 VLE Clips of at least 20 seconds featuring one or more the VLE criteria. All clips will have confirmed diagnosis for accuracy analysis. All clips will be de-identified. All clips will be removed from RedCAP and other secure cloud storage upon completion of study.

Clips will be supplied by NinePoint Medical, the company behind VLE OCT. All VLE clips will be from a dataset of clips collected from adults \> 18 and who underwent Endoscopic retrograde cholangiopancreatography (ERCP) with indeterminate biliary stricture indications. The clips are chosen based on the quality of the clips, duration, final diagnosis and presence of either benign or malignant criteria.

Investigators: Up to 30 Expert and non-expert endoscopists currently using VLE

Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study

Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity

Correlation analysis of any of the 9 visual criteria with malignancy diagnosis as determined by endoscopist

Learning curve using CUSUM analysis to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management proficiently.

NinePoint Medical

Innovative Digestive Health Education and Research Inc

Pancreatitis

Pancreatitis, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

brushing of bile duct strictures for cytology

The purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at RedPATH. In some patients additional brushings will be obtained for FISH testing (this adds \<2 minutes to ERCP and only associated risk is increased procedure duration).

The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity and accuracy when compared to cytology +FISH in patients with biliary strictures.

Primary aim:

To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy.

Secondary aims:

1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used.
2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.

Diagnosis of Bile Duct Strictures

The Diagnostic Yield of Malignancy Comparing Cytology, FISH and Molecular Analysis of Cell Free Cytology Brush Supernatant in Patients With Biliary Strictures Undergoing Endoscopic Retrograde Cholangiography (ERC): A Prospective Study

Washington University School of Medicine

Gallbladder Diseases

Add a transparent cap to the end of the SpyGlass choledochoscopy

Add a self-made transparent cap (made by cutting a silicone drainage tube) to the end of the SpyGlass choledochoscope, and then perform routine choledochoscopy and biopsy operations

Transparent cap

Yan Liu, MD

Liang Wu, MD

The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. In this study, the investigators intend to apply transparent cap-assisted choledochoscopy to endoscopic biliary tract exploration and biopsy to investigate whether transparent cap-assisted choledochoscopy can improve operability, visual field clarity, and biopsy accuracy.

Recently, endoscopy has become more widely used in clinical practice. A straightforward method of improving mucosal visualization involves attachment of a transparent cap to the end of the endoscope. It has been widely used in gastrointestinal examination and treatment.This is a before-after study. In patients with suspected bile duct stricture, tandem ERCP combined with SpyGlass choledochoscopy procedures were carried out on the same day in random order, first without a transparent cap and then with a cap (without-to-with), or first with a cap and then without a cap (with-to-without). The differences in maneuverability, visual field clarity and biopsy accuracy of choledochoscopy with and without transparent cap were recorded to explore the application prospect of transparent cap assisted choledochoscopy.

This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.

Transparent Cap-assisted SpyGlass for Biliary Stricture

Application of Transparent Cap-assisted Digital Cholangioscopy (SpyGlassTM) for Biliary Stricture

The clearness of visual field was evaluated by the operating physician and was rated as "clear" or "not clear."

Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass

Biopsy accuracy between clear cap SpyGlass and standard SpyGlass was evaluated by comparing the coincidence rate of biopsy histopathology and postoperative pathology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Performance of FISH for the Diagnosis of Malignant Biliary Strictures in Thai Patients	NCT02442167	Bile Duct Stric... Malignancy		18 Years -	Mayo Clinic
Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study	NCT03951324	Biliary Strictu... Pancreas Cancer Cholangiocarcin... Bile Duct Cance... Bile Duct Neopl... Bile Duct Neopl... Bile Duct Lesio... Bile Duct Obstr... Bile Duct Disea... Bile Duct Obstr... Bile Duct Steno... Bile Duct Adeno... Pancreatic Duct... Pancreatic Duct... Pancreatic Duct... Pancreatic Duct... Primary Scleros...	Interobserver a...	18 Years -	Innovative Digestive Health Education and Research Inc
Diagnosis of Bile Duct Strictures	NCT02000999	Bile Duct Stric... Cholangiocarcin... Pancreatic Canc... Chronic Pancrea...	brushing of bil...	18 Years - 99 Years	Washington University School of Medicine
Transparent Cap-assisted SpyGlass for Biliary Stricture	NCT05320497	Bile Duct Stric... Endoscopic Retr... Biliary Disease Biliary Tract N...	Transparent cap	18 Years -	Affiliated Hospital to Academy of Military Medical Sciences
Performance of FISH for the Diagnosis of Malignant Biliary Strictures in Thai Patients	NCT02442167	Bile Duct Stric... Malignancy		18 Years -	Mayo Clinic
Transparent Cap-assisted SpyGlass for Biliary Stricture	NCT05320497	Bile Duct Stric... Endoscopic Retr... Biliary Disease Biliary Tract N...	Transparent cap	18 Years -	Affiliated Hospital to Academy of Military Medical Sciences

Spots Global Cancer Trial Database for bile duct stricture