The use of intraoperative imaging techniques will improve sensitivity for detection of peritoneal metastases of colorectal origin
ID
Bron
Aandoening
peritoneal metastases, peritoneal carcinomatoris, colorectal cancer, imaging techniques, fluorescence, narrow-band imaging, ICG, 5-ALA
peritoneale metastasen, peritonitis carcinmatosa, colorectaal carcinoom, beeldvormende technieken, fluorescentie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To 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.
Achtergrond van het onderzoek
Rationale: 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.
Doel van het onderzoek
The use of intraoperative imaging techniques will improve sensitivity for detection of peritoneal metastases of colorectal origin
Onderzoeksopzet
intraoperative evaluation
Onderzoeksproduct en/of interventie
Administration of either Indocyanine Green (ICG) or 5-aminolevulinic acid (5-ALA) preoperatively
Publiek
Stijn Vlek
de Boelelaan 1118
Amsterdam 1081 HV
The Netherlands
019 - 020 444 44 400
s.vlek@vumc.nl
Wetenschappelijk
Stijn Vlek
de Boelelaan 1118
Amsterdam 1081 HV
The Netherlands
019 - 020 444 44 400
s.vlek@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Orally and written informed consent
• Age 18 years and older
• Elective cytoreductive surgery followed by HIPEC
• Regular preoperative work-up
• Laparoscopic approach
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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)
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5676 |
| NTR-old | NTR5820 |
| CCMO | NL50797.029.15 |
| OMON | NL-OMON44157 |