Cholangioscopy in intraductal staging of resectable extrahepatic CholangioCarcinoma
- Conditions
- bile duct cancercholangiocarcinoma1001800810019815
- Registration Number
- NL-OMON52099
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
- Patients with resectable EC undergoing ERCP to achieve pre-operative biliary
decompression of the FRL
- (Suspicion of) EC is based on clinical assessment and imaging results
(MRI/MRCP and CT), histological confirmation is not obligatory.
- Resectability of the tumor was evaluated at the regional multidisciplinary
team meeting
- Biliary stenosis located distally, or perihilar according to Bismuth
classification based on imaging results (MRI/MRCP/CT)
- Informed consent
- Age >= 18 years
• Intrahepatic cholangiocarcinoma
• Irresectable tumor
• Previous treatment with a biliary plastic endoprothesis or self-expandable
metal stent (SEMS)
• Previous treatment with a percutaneous transhepatic biliary drain
• Patients with expected very limited survival (< 6 weeks)
• Biliary obstruction not amenable to endoscopic drainage, for example due to
altered anatomy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Technical feasibility to perform cholangioscopy in EC, defined as the technical<br /><br>success to advance the Spyglass DS II cholangioscope through the malignant<br /><br>stricture into the intended (segmental) bile duct system(s), to assess ductal<br /><br>tumor borders optically and to obtain mapping biopsies of the locations of<br /><br>interest depending on the predetermined resection lines. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Overall diagnostic value of optical cholangioscopic assessment combined with<br /><br>biopsies of bile duct locations at interest outside the predetermined resection<br /><br>lines.<br /><br><br /><br>2. Diagnostic value of optical cholangioscopic assessment or biopsies alone.<br /><br><br /><br>3.Adverse outcomes after cholangioscopy defined by any cholangioscopy-related<br /><br>AE or mortality within 30 days. The AE will be recorded according the ASGE<br /><br>lexicon.</p><br>