Plain English Summary
Background and study aims
Bile is a substance produced by the liver and stored in the gall bladder, which is secreted into the small intestine to help digest fats from the diet. Common bile duct stenosis is the narrowing of the bile duct which blocks bile from being released, leading to problems with digestion. This condition can be malignant (cancerous) or benign (non-cancerous), but this is very hard to determine and can only be done reliably through surgery. It is important to determine this as malignant bile duct stenosis could be a sign of pancreatic cancer. Studies have shown that cancer cells release more extracellular vesicles (EVs) (packages released by cells that surround the membrane) as compared to healthy cells. It is estimated that using EVs as a marker for malignancy through measuring specific markers found in the tissue can help differentiate between malignant and benign stenosis. This study aims to determine if the measurement of EV concentration in bile could improve determining between malignant and benign common bile duct stenosis.
Who can participate?
Adults over the age of 16 who require their bile duct to be unblocked (biliary catheterization)
What does the study involve?
Participants have their bile duct unblocked through an endoscopic procedure (a long thin tube that has a light and a camera inserted through a small incision) which uses a catheter (a long thin tube), that is inserted through a small incision in the abdomen, into the bile duct area to remove bile. Bile samples are taken and are sent to a laboratory for analysis. Participants are followed up for one year to make sure they do not have malignant bile duct stenosis.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants.
Where is the study run from?
Geneva University Hospital (Switzerland)
When is the study starting and how long is it expected to run for?
August 2006 to December 2015
Who is funding the study?
Geneva University Hospital (Switzerland)
Who is the main contact?
Jean Louis Frossard
jean-louis.frossard@hcuge.ch
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Extracellular vesicles in human bile as a novel and accurate marker of malignant biliary stenoses
Acronym
Study hypothesis
This study aims to determine if the measurement of EV concentration in bile could improve the clinical discrimination between malignant and nonmalignant CBD stenosis.
Ethics approval
1. Ethical Committee Geneva,08/08/2006, ref: GE 04-091
2. Ethical Committee Université libre de Bruxelles, Erasmus Hosptial, 02/11/2009, ref: P2009/007, CCB B 40620095782
Study design
Observational multi-center longitudinal case-control study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Common bile duct stenosis
Intervention
Participants undergo a biliary catheterization through endoscopic exploration of the biliary tract. This involves bile being removed from the common bile duct after it has been aspirated. Bile is aliquoted into eppendorf tubes (5ml) and frozen to -20 ºC and stored at a laboratory in Geneva. The bile samples examined through laboratory analysis for markers of malignant and nonmalignant common bile duct stenosis.
The first ten consecutive patients are assigned to the discovery cohort together with ten bile duct stones patients (i.e., internal controls proven nonmalignant) before endoscopy. The remaining 30 patients are assigned to the verification cohort before endoscopy is performed. Final diagnosis is determined by pathological examination of tissue sample in all patients with common bile duct stenosis.
Participants are are clinically followed up for 1 year to show no sign of malignancy with a common bile duct stenosis related to chronic pancreatitis. Follow up will include clinical history with patient interview, measurement of CA-19.9 and imaging modalities. For bile duct stone patients, the diagnosis is based on radiological and endoscopic features.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Extracellular vesicles (EVs) are evaluated by transmission electron microscope (TEM) and nanoparticle tracking analysis (NTA) and through medical interviews at baseline and 12 months
2. Serum bilirubin and CA19.9 are measured in all patients at baseline
Secondary outcome measures
Performance of extracellular vesicles (EVs) is assessed through tumor markers (including CA19-9) at baseline
Overall trial start date
08/08/2006
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients scheduled for biliary catheterism due to obstructive jaundice or cholestasis of biliary origin (suspicion of cancer, suspicion of stones, chronic pancreatitis)
2. Age > 16 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 in total. 20 for the discovery part of the study and 30 for the confirmation cohort
Participant exclusion criteria
1. Less than 16 years old
2. Pregnant women
Recruitment start date
02/11/2009
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Belgium, Switzerland
Trial participating centre
Service of Gastroenterology and Hepatology
Geneva University Hospital
R G Perret Gentil 14
Genève
1211
Switzerland
Trial participating centre
Service of Gastroenterology
Erasme University Hospital
Route de Lennik 808
Brussels
10170
Belgium
Sponsor information
Organisation
Service of Gastroenterology and Hepatology
Sponsor details
Geneva University Hospital
R G Perret Gentil 14
Genève
1211
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Geneva University Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal by end of 2017.
IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jean Louis Frossard (jean-louis.frossard@hcuge.ch).
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28479376