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Advanced imaging in HIPEC for peritoneal carcinomatosis of colorectal origin; a feasibility study

Completed
Conditions
Peritoneal Carcinomatosis
Peritoneal Metastases
10034652
10027476
10017998
Registration Number
NL-OMON44157
Lead Sponsor
Vrije Universiteit Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
28
Inclusion Criteria

-Oral and written informed consent
-Age 18 years and older
-Elective cytoreductive surgery followed by HIPEC
-Regular preoperative work-up
-Laparoscopic or open approach

Exclusion Criteria

-ASA score higher than 3
-Patients who have had prior major open abdominal surgery
-Contraindicattions for ICG, 5-ALA or ICB
-Medication that interacts with ICG, 5-ALA or ICB
-Chronic kidney failure (eGFR < 55)
-Chronic liver failure (ASAT, ALAT, AF or yGT > 2 times normal value)

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To evaluate the sensitivity of Narrow Band Imaging, Three-dimensional imaging,<br /><br>Near-infrared Indocyanin Green Imaging, 5-ALA fluorescent imaging and Indigo<br /><br>Carmine Blue Spray Dye Chromoendoscopy in the detection of malignant lesions.<br /><br><br /><br>To evaluate if more malignant lesions are found with NBI, 3D, NIR-ICG, 5-ALA<br /><br>and SDCE, compared to conventional white light laparoscopy.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Operating time<br /><br>Blood loss<br /><br>Peritoneal carcinomatosis index (PCI) score<br /><br>(Serious) adverse events<br /><br>Patient characteristics<br /><br>Tumour characteristics</p><br>
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