Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer
NCT02123407 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2014-04-25
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.
Conditions
- Advanced Gastric Cancer
Interventions
- DRUG
-
Carbon Nanoparticles
Carbon Nanoparticles will be injected into the subserosa of stomach around the tumor.Gastrectomy with D2 dissection will be performed after the injection.
- PROCEDURE
-
Gastrectomy with D2 dissection
In the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials.
Sponsors & Collaborators
-
Peking University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2014-06-30
Countries
- China
Study Locations
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