ISRCTN ISRCTN66835592
DOI https://doi.org/10.1186/ISRCTN66835592
Secondary identifying numbers N/A
Submission date
31/01/2017
Registration date
02/02/2017
Last edited
11/07/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Jean Louis Frossard
Scientific

Service of Gastroenterology and Hepatology, Geneva University Hospitals
Genève
1211
Switzerland

Study information

Study designObservational multi-center longitudinal case-control study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleExtracellular vesicles in human bile as a novel and accurate marker of malignant biliary stenoses
Study objectivesThis 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(s)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
Health condition(s) or problem(s) studiedCommon bile duct stenosis
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measuresPerformance of extracellular vesicles (EVs) is assessed through tumor markers (including CA19-9) at baseline
Overall study start date08/08/2006
Completion date31/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50 in total. 20 for the discovery part of the study and 30 for the confirmation cohort
Key inclusion criteria1. 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
Key exclusion criteria1. Less than 16 years old
2. Pregnant women
Date of first enrolment02/11/2009
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Belgium
  • Switzerland

Study participating centres

Service of Gastroenterology and Hepatology
Geneva University Hospital
R G Perret Gentil 14
Genève
1211
Switzerland
Service of Gastroenterology
Erasme University Hospital
Route de Lennik 808
Brussels
10170
Belgium

Sponsor information

Service of Gastroenterology and Hepatology
Hospital/treatment centre

Geneva University Hospital
R G Perret Gentil 14
Genève
1211
Switzerland

Website www.hcuge.ch
ROR logo "ROR" https://ror.org/01m1pv723

Funders

Funder type

Not defined

Geneva University Hospital

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal by end of 2017.
IPD sharing planThe 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).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2017 Yes No

Editorial Notes

11/07/2018: Publication reference added.