Condition category
Digestive System
Date applied
31/01/2017
Date assigned
02/02/2017
Last edited
02/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Jean Louis Frossard

ORCID ID

Contact details

Service of Gastroenterology and Hepatology
Geneva University Hospitals
Genève
1211
Switzerland

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 below 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 (ie 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 measures

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

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

www.hcuge.ch

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes