No registrations found.
ID
Source
Brief title
Health condition
Gastric cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Tumor-to-background ration, accuracy, sensitivity, specificity.
Background summary
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.
Study objective
Fluorescent near-infrared imaging can accurately detect lymph nodes non-invasively during SLN mapping in gastric cancer patients.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
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.
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
gastric cancer patients scheduled for (partial)
gastric resection and lymphadenectomy.
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 | NL4129 |
| NTR-old | NTR4280 |
| Other | METC LUMC : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |