Advanced Gastric Cancer
Conditions
Keywords
Advanced Gastric Cancer, Carbon Nanoparticles, Lymph Nodes
Brief summary
Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some small ones. but there was insufficient evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a prospective randomized controlled trial on lymph node vital staining for lymph node dissection and harvesting in advanced gastric cancer to test this idea.
Detailed description
Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some small ones. but there was insufficient evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a prospective randomized controlled trial on lymph node vital staining for lymph node dissection and harvesting in advanced gastric cancer to test this idea.
Interventions
Carbon Nanoparticles will be injected into the subserosa of stomach around the tumor.Gastrectomy with D2 dissection will be performed after the injection.
PROCEDUREGastrectomy with D2 dissection
In the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically and CT confirmed resectable advanced gastric cancer * No prior treatment * No metastases
Exclusion criteria
* Having allergic reaction * Pregnant * R0 resection is not achieved by gastrectomy with D2 lymphadenectomy according to Japanese gastric cancer treatment guidelines 2010 (ver. 3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the number of harvested lymph nodes | 1 day after operation |
Secondary
| Measure | Time frame |
|---|---|
| the diameter of harvested lymph nodes | 1 day after operation |
Countries
China
Contacts
Primary ContactJiafu Ji, master
Outcome results
None listed