Peritoneal carcinomatosis from colorectal origin MedDRA version: 18.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ICG-Pulsion
Product Name: ICG-Pulsion
Product Code: N/A
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Indocyanin green
CAS Number: 3599-32-4
Other descriptive name: INDOCY
Sponsors
VU University medical center (VUmc)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Oral and written informed consent • Age 18 years and older • Elective cytoreductive surgery followed by HIPEC • Regular preoperative work-up • Laparoscopic approach Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 • Hypersensitivity reaction to prior usage of indigo carmine or other dyes • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluate tumour detection sensitivity and specificity with the following image enhancement modalities: - 1 ‘narrow-band imaging’, 2 ‘autofluorescent imaging’, 3 ‘near-infrared indocyanin green imaging’, 4 ‘5-aminolevulinic acid fluorescent imaging’, 5 ‘three-dimensional imaging’ and 6 ‘spray-dye chromoendoscopy’ compared to conventional white light laparoscopy in patients with peritoneal carcinomatosis in order to achieve best tumour detection. ;Secondary Objective: - To evaluate if the use of narrow-band imaging is feasible for this procedure. - To evaluate if the use of autofluorescent imaging is feasible for this procedure. - To evaluate if the use of intravenous indocyanin green injection visualized by near-infrared imaging is safe and feasible for this procedure. - To evaluate if the use of fluorescent imaging with 5-aminolevulinic acid is safe and feasible for this procedure. - To evaluate if the use of three-dimensional imaging is feasible for this procedure. - To evaluate if the use of spray-dye chromoendoscopy with indigo carmine blue is safe and feasible for this procedure. - To evaluate extra operating time by the use of these image enhancement modalities - To evaluate possible adverse effects ;Primary end point(s): -Evaluate tumour detection sensitivity and specificity with the following image enhancement modalities: 1 ‘narrow-band imaging’, 2 ‘autofluorescent imaging’, 3 ‘near-infrared indocyanin green imaging’, 4 ‘5-aminolevulinic acid fluorescent imaging’, 5 ‘three-dimensional imaging’ and 6 ‘spray-dye chromoendoscopy’ compared to conventional white light laparoscopy in patients with peritoneal carcinomatosis in order to achieve best tumour detection. ;Timepoint(s) of evaluation of this end point: After the surgical procedure when pathological examination of the specimen and biopsies is completed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate if the use of narrow-band imaging is feasible for this procedure. - To evaluate if the use of autofluorescent imaging is feasible for this procedure. - To evaluate if the use of intravenous indocyanin green injection visualized by near-infrared imaging is safe and feasible for this procedure. - To evaluate if the use of fluorescent imaging with 5-aminolevulinic acid is safe and feasible for this procedure. - To evaluate if the use of three-dimensional imaging is feasible for this procedure. - To evaluate if the use of spray-dye chromoendoscopy with indigo carmine blue is safe and feasible for this procedure. - To evaluate extra operating time by the use of these image enhancement modalities - To evaluate possible adverse effects ;Timepoint(s) of evaluation of this end point: After the surgical procedure when pathological examination of the specimen and biopsies is completed | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Surgery
VU University Medical Center
Outcome results
None listed