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.
ID
Bron
Verkorte titel
Aandoening
Bowel cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Percentage of patients in whom SLN identification was possible using NIR fluorescence imaging<br>
2. Percentage of patients in whom intraopertive detection of the tumor border was possible by NIR fluorescence imaging
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Colorectal cancer patients scheduled for laparoscopic low anterior resection.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4541 |
| NTR-old | NTR4682 |
| Ander register | : P09.001 METC LUMC |