Identification of the sentinel lymph node (SLN) in patients with colon carcinoma.
- Conditions
- Colon carcinomaTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2021-006700-32-NL
- Lead Sponsor
- Meander Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 5
- Oral and written informed consent (IC)
- Aged 18 years and older
- Pathologically confirmed and/or suspected cT1-3N0-2M0 colon carcinoma
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 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 3
- Distant metastasis
- Suspicion of cT4 disease based on pre-operative assessment
- Metastatic or T4 disease discovered during intraoperative staging
- Pregnancy, lactation or a planned pregnancy during the course of the
study
- Previous colon surgery, excluding appendectomy.
- Contra-indication for laparoscopic/robotic surgery
- Inadequately controlled hypertension with or without current antihypertensive medication.
- Within 6 months prior to inclusion: myocardial infarction, TIA, CVA, pulmonary embolism, unstable angina pectoris, or uncontrolled chronic hepatic failure.
- Regarding bevacizumab: Hypersensitivity to Chinese Hamster Ovary
(CHO) cell products or other recombinant human or humanised
antibodies. Or an allergy for its components (Trehalose dehydrate,
sodium phosphate, polysorbate 20, water for injections)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method