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van CCT (UK)

van CCT (UK)

Het beter in beeld krijgen van uitzaaiingen tijdens een HIPEC operatie bij patiënten met dikke darm kanker uitzaaiingen in het buikvlies

- candidate number24183
- NTR NumberNTR5820
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-apr-2016
- Secondary IDsNL 50797.029.15 
- Public TitleHet beter in beeld krijgen van uitzaaiingen tijdens een HIPEC operatie bij patiënten met dikke darm kanker uitzaaiingen in het buikvlies
- Scientific TitleAdvanced imaging in laparoscopic HIPEC for peritoneal carcinomatosis of colorectal origin; a feasibility study
- hypothesisThe use of intraoperative imaging techniques will improve sensitivity for detection of peritoneal metastases of colorectal origin
- Healt Condition(s) or Problem(s) studiedPeritoneal metastasis, Colorectal cancer, Imaging
- Inclusion criteria• Orally and written informed consent
• Age 18 years and older
• Elective cytoreductive surgery followed by HIPEC
• Regular preoperative work-up
• Laparoscopic approach
- Exclusion criteria• Patients who are legally or mentally incapable or unable to give informed consent
• Patients younger than 18 years
• ASA (American Society of Anaesthesiologists) score higher than 3
• Exclusion criteria for cytoreductive surgery followed by HIPEC
• Exclusion criteria for resection of colorectal cancer
• Patients who have had major open abdominal surgery
• Open-close procedure (peritoneal metastases are to vast for resection)
• Hypersensitivity reaction to prior usage of indigo carmine
• Severe high blood pressure, cardiac ischemia and heart insufficiency
• Iodine allergy
• Patients with hyperthyroidism or autonomous hyperthyroid adenoma
• Interaction with any of the following medication: any anticonvulsive medicine, bisulphites, haloperidol, heroin, meperidine, metamizol, methadone, morfine, nitrofurantoine, opiate alkaloids, fenobarbital, fenylbutazon, cyclopropane, probenicid, rifamycin, tetracyclines, sulphonamides, fluoroquinolones and hypericin extracts
• Hypersensitivity reaction to prior usage of indocyanin green injection
• Hypersensitivity to 5-ALA or porphyrins
• Acute or chronic types of porphyria
• Urgent indication for surgery
• Pregnancy
• Chronic kidney failure (eGFR<55)
• Chronic liver failure (ASAT, ALAT, AF or yGT > two times max normal value)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 15-apr-2016
- planned closingdate15-apr-2017
- Target number of participants20
- InterventionsAdministration of either Indocyanine Green (ICG) or 5-aminolevulinic acid (5-ALA) preoperatively
- Primary outcomeTo evaluate the sensitivity and specificity of Narrow Band Imaging, Near-infrared Indocyanin Green Imaging, 5-ALA fluorescent imaging and Indigo Carmine Blue Spray Dye Chromoendoscopy in the detection of malignant lesions.
- Secondary outcomePeritoneal carcinomatosis index (PCI) score
- Timepointsintraoperative evaluation
- Trial web site
- statusstopped: trial finished
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summaryRationale: The presence of peritoneal metastasis is a poor prognostic factor for patients with colorectal cancer. Without treatment median survival is 3 months. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) improves survival significantly with a median of 22.3 months. Current difficulty is detection of small peritoneal metastases, in order to achieve complete cytoreduction. Enhanced imaging could potentially increase detection rate and improve cytoreduction. Next to high definition endoscopic imaging, other image-enhancement modalities. such as narrow-band imaging (NBI), ‘near-infrared indocyanin green fluorescent imaging’ (NIR-ICG), photodynamic diagnosis with 5-amino levulinic acid (5-ALA) and spray-dye chromoendoscopy (SDCE) can enhance conventional white-light detection and therefore lead to a more complete extent of cytoreduction and better survival.

Objective: Our primary objective is to improve tumour detection rate by using enhanced imaging modalities (NBI, NIR-ICG, 5-ALA and SDCE).

Study design: Safety and feasibility study

Study population: Patients with radiological and/or clinically proven peritoneal carcinomatosis of colorectal origin.

Intervention: Patients undergo exploratory laparoscopy or laparotomy of the regions suspected for malignant lesions by conventional white light, NBI, NIR-ICG, 5-ALA and SDCE, prior to CRS followed by HIPEC. 5-ALA and ICG will not be administered in the same patients.

Main study parameters/endpoints: To evaluate the sensitivity and specificity of tumour detection of these four image enhancement modalities compared to conventional white light. Reference standard will be the result of the pathological examination of the biopsy.
- Main changes (audit trail)
- RECORD4-apr-2016 - 21-apr-2018

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