Cholangiocarcinoma detection using an intraOperative FlUorescence Image Guided Approach with Bevacizumab-IRDye 800CW

Recruiting

Conditions: bile duct cancer
10019813

Registration Number: NL-OMON46827

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Age older or equal to 18 year
- Patients with suspected perihilar cholangiocarcinoma who are scheduled to undergo surgical intervention with curative intent
- WHO performance score 0-2

Exclusion Criteria

- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Other invasive malignancy
- Pregnant or lactating women.
- History of infusion reactions to bevacizumab
- Inadequately controlled hypertension with or without current antihypertensive medications
- Within 6 months prior to inclusion: myocardial infarction, TIA, CVA, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Standard histopathological examination to confirm higher fluorescent signals<br /><br>in tumour tissue compared to normal tissue.<br /><br>- Calculating target to background ratios in fluorescence images obtained<br /><br>during and directly after the surgical procedure and fluorescence images<br /><br>obtained during ex vivo analyses in bread loaf slices and in histological<br /><br>slices (odyssey scanner, fluorescence microscopy).<br /><br>- Determining the tracer distribution at microscopic level using needle based<br /><br>confocal laser endomicroscopy during ex vivo off table imaging.<br /><br>- Measuring fluorescent signal using spectroscopy to correct for scattering.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Intraoperative assessment of positive margins based on fluorescent images.<br /><br>- Off table imaging of surgical specimen directly after excision to identify<br /><br>positive margins, lymph nodes and metastases based on ex vivo fluorescent<br /><br>images.<br /><br>- Back table imaging of surgical specimen after excision to identify tumour<br /><br>tissue by NIR endoscopy based on ex vivo fluorescent images .</p><br>