No registrations found.
ID
Source
Brief title
Health condition
Bowel cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. 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 outcome
Time difference between visualization of fluorescence signal and Indian ink tattoo. Sensitivity of SLN procedure.
Background summary
The 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.
Study objective
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.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
After 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.
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Inclusion criteria
Colorectal cancer patients scheduled for laparoscopic low anterior resection.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4541 |
| NTR-old | NTR4682 |
| Other | : P09.001 METC LUMC |