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Intra-operative fluorescent imaging of the tumor border and sentinel lymph nodes in rectal and sigmoid cancer


- candidate number18313
- NTR NumberNTR4682
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jul-2014
- Secondary IDsP09.001 METC LUMC 
- Public TitleIntra-operative fluorescent imaging of the tumor border and sentinel lymph nodes in rectal and sigmoid cancer
- Scientific TitleIntra-operative fluorescent imaging of the tumor border and sentinel lymph nodes in rectal and sigmoid cancer
- ACRONYMGREEN LIGHT
- hypothesisIntraoperative endoscopic marking of the tumor can assist in detection of tumor border and possibly decrease tumor involvement of the resection margin. Moreover, intraoperative endoscopic marking of the tumor can result in detection of the SLNs.
- Healt Condition(s) or Problem(s) studiedBowel cancer, Sentinel lymph node
- Inclusion criteriaColorectal cancer patients scheduled for laparoscopic low anterior resection.
- Exclusion criteria1. History of allergy to iodine, shellfish, indocyanine green or nanocolloid;
2. Pregnancy;
3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 28-okt-2013
- planned closingdate28-okt-2014
- Target number of participants20
- InterventionsAfter general anesthesia, prior to incision, ICG;NanoColl will be injected endoscopically around the tumor. During surgery, fluorescence imaging will be performed to visualize tumor border and lymph nodes.
- Primary outcome1. Percentage of patients in whom SLN identification was possible using NIR fluorescence imaging
2. Percentage of patients in whom intraopertive detection of the tumor border was possible by NIR fluorescence imaging
- Secondary outcomeTime difference between visualization of fluorescence signal and Indian ink tattoo. Sensitivity of SLN procedure.
- TimepointsThe primary and secondary outcomes will be assessed during surgery and pathological assessment.
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.J.H. Velde, van de
- CONTACT for SCIENTIFIC QUERIESMD PhD A.L. Vahrmeijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsNA
- Brief summaryThe SLN procedure has been proposed to improve nodal staging in colorectal cancer patients. Moreover, the resection margins is prognostic in survival after rectal cancer surgery. Current treatment includes neoadjuvant chemoradiation therapy, which often result in regression of the tumor. This makes intraoperative tumor detection more difficult. Intraoperative endoscopic marking of the tumor can assist in detection of tumor border and possibly decrease tumor involvement of the resection margin. Moreover, intraoperative endoscopic marking of the tumor can result in detection of the SLNs.
- Main changes (audit trail)
- RECORD8-jul-2014 - 10-aug-2014


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