Optimalisation of tumor identification during HIPEC surgery in patients with metastasis from colon cancer on their peritoneum

Phase 1

• Conditions: Peritoneal carcinomatosis from colorectal origin; MedDRA version: 18.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003932-38-NL
• Lead Sponsor: VU University medical center (VUmc)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-07
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified