Fluorescent near-infrared imaging can accurately detect lymph nodes non-invasively during SLN mapping in gastric cancer patients.
ID
Bron
Verkorte titel
Aandoening
Gastric cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Identification rate, defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes was identified with the fluorescent signal of ICG:Nanocoll.
Achtergrond van het onderzoek
SLN technique has been used in the management of a variety of cancers to avoid unnecessary lymphadenectomy, and also in gastric cancer several studies support the validity of the SLN concept.
Fluorescent imaging using near-infrared probes is an innovative technique to directly visualize lymphatic pathways and lymph nodes.
Previous studies already used indocyanine green (ICG) in SLN mapping in gastric cancer and were able to successfully identify SLN with either preoperative submucosal and intraoperative subserosal injections around the tumor. Less false negative cases were found after preoperative submucosal injection. However, also a more widely spread of ICG in the lymphatic vessels with time, which results in the detection of more 2nd-tier nodes.
Recent publications showed good retention in the SLN with ICG coupled to a nanocolloid.
The aim of the study is to determine the proportion of gastric cancer patients in whom SLNs can be identified non-invasively with fluorescent imaging using ICG coupled to a nanocolloid (ICG:Nanocoll) during standard lymphadenectomy.
Doel van het onderzoek
Fluorescent near-infrared imaging can accurately detect lymph nodes non-invasively during SLN mapping in gastric cancer patients.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Onderzoeksproduct en/of interventie
Standard lymphadectomy will be performed. During surgery, the near-infrared dye ICG:Nanocoll will be injected around the tumor and lymphatic pathways and lymph nodes will be visualized non-invasively using our experimental camerasystem.
Publiek
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
Wetenschappelijk
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)
gastric cancer patients scheduled for (partial)
gastric resection and lymphadenectomy.
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 | NL4129 |
NTR-old | NTR4280 |
Ander register | METC LUMC : P09.001 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |