Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Constriction, Pathologic

Cholestasis

Bile Duct Neoplasms

Cholestasis, Extrahepatic

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Bile Duct Diseases

Biliary Tract Diseases

Biliary Tract Neoplasms

Pancreatic Cancer

Bile Duct Cancer

Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.

Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture

Palliation of malignant biliary obstruction

Biliary stent

Marc M Bernon, MBBCh

A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.

Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction

Treatment of Malignant Distal Biliary Obstruction - a Randomized Study

Number of patients without Stent failure (jaundice) or death with a patent stent

Number of patietns alive in each group at 12 months

Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation

The differance in treatment costs between the two groups, measured in USD

University of Cape Town

Senior consultant

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antibodies

Immunoglobulins

This arm includes patients with bile duct stenosis. Endobiliary brushing cytology specimens will be obtained with endoscopic retrograde cholangiopancreatography (ERCP) of patients with bile duct stenosis. Cytology staining will be performed in the cytology specimens.

Two staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography

1. conventional cytology staining method
2. new cytology staining method using antibody of aminoacyl-tRNA synthetases

Cytology staining

Institutional Review Board

The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to develop a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer related protein expressed only in bile duct cancer.

Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.

Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by new staining method and compare with the results of conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.

The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.

Development of a New Immunochemistry Method Using Antibodies of Proteins Related Bile Duct Cancer

Development of a New Immunochemistry Method Using Antibodies of Aminoacyl-tRNA Synthetases Group and Aminoacyl-transfer Ribonucleic Acid Synthetases-interacting Multifunctional protein2 Lacking Exon 2 in the Bile Duct Cancer Cell; Multicenter Study

We plan to share the following individual participant data with other researchers during study period.

Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code

The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of new staining method will be compared with th conventional Pap staining of brushing cytology specimens.

Korea Institute of Science and Technology

Gangnam Severance Hospital

Assistant professor, MD, PhD

Adenoma

Cholangitis

Cholangitis, Sclerosing

Adenoma, Bile Duct

Papilloma, Intraductal

Pathological Conditions, Anatomical

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

Two stainings will be performed in cytology specimens obtained from the same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography

1. conventional cytology staining method
2. new cytology staining method using the antibody of aminoacyl-tRNA synthetases

Sung Ill Jang, MD, PhD

Chang-Il Kwon, MD., Ph.D

Sung Ill Jang, MD., Ph.D

Jung Seuk, MD., Ph.D

Tae Hoon Lee, MD., Ph.D

Dong Uk Kim, MD., Ph.D

The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to validate the clinical usefulness of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer-related protein expressed only in bile duct cancer.

Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.

Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by a new staining method and compare with the results of the conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunocytochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.

The conventional staining method and new staining method will be performed in cytology specimens obtained from the same patient.

Clinical Validation of an Immunocytochemistry Method Using MARS1

Clinical Validation of an Immunocytochemistry Method Using Antibody of Methionyl-tRNA Synthetase (MARS1) in the Bile Duct Cancer Cell; Multicenter Study

We plan to share the following individual participant data with other researchers during the study period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction	NCT03821025	Bile Duct Obstr... Cancer of the P... Cancer of the B... Biliary Strictu...	Biliary stent	18 Years -	University of Cape Town
Development of a New Immunochemistry Method Using Antibodies of Proteins Related Bile Duct Cancer	NCT03708445	Bile Duct Obstr...	Cytology staini...	19 Years -	Gangnam Severance Hospital
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
Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction	NCT03821025	Bile Duct Obstr... Cancer of the P... Cancer of the B... Biliary Strictu...	Biliary stent	18 Years -	University of Cape Town
Clinical Validation of an Immunocytochemistry Method Using MARS1	NCT04759794	Bile Duct Obstr...	Cytology staini...	19 Years -	Gangnam Severance Hospital

Spots Global Cancer Trial Database for bile duct obstruction, extrahepatic