Aim of this study is to assess the value of cholangioscopic directed biopsies versus brush cytology in differentiating between malignant and benign biliary strictures. Determination of tumor markers to improve early diagnosis of malignant biliary…
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Bile duct disorders
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The difference in sensitivity between brush cytology en cholangioscopic
directed biopsy for detection of patients with malignant biliary stricture.
2. Cholangioscopic aspect of stricture
Secondary outcome
Duration of examination
Background summary
It is important to differentiate between malignant and benign bile duct
stenoses. Direct tissue sampling with brush cytology yields low sensitivity
rates that makes this method insufficient for definitive treatment decisions.
New cholangioscopes and biopsy forceps are developed. Aim of this study is to
assess the value of cholangioscopic directed biopsies versus brush cytology in
differentiating between malignant and benign biliary strictures.
Also, we want to collect extra tissue, plasma and fecal samples for
determination of tumor markers.
Study objective
Aim of this study is to assess the value of cholangioscopic directed biopsies
versus brush cytology in differentiating between malignant and benign biliary
strictures.
Determination of tumor markers to improve early diagnosis of malignant biliary
strictures.
Study design
prospective study
Study burden and risks
Patients have got indications for ERCP and the cholangioscopic examination is
an extra supplement to the diagnostic proces. No extra sessions are necessary.
The subjects will be emitted in the hospital for two days.
ERCP has got risks such as bleeding, perforation and post-ERCP pancreatitis.
No extra examinations, hospital or outpatients visits are necessary.
Dr. Molewaterplein 40
3015 GD Rotterdam
NL
Dr. Molewaterplein 40
3015 GD Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 year
icterus (bilirubine >2xULN)
Cholestasis (GGT or alk fos >2xULN)
dilated bile ducts on imaging with abdominal ultrasound, CT, or MRI
Exclusion criteria
Distal CBD stenosis
Clinical conditions that do not allow ERCP with sphincterotomy such as uncorrectable coagulopathies
High suspicion of common bile duct stones
Patients unable or not willing to give informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17488.078.07 |