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UnknownNCT02123407

Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer

Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer:a Prospective Randomized Study

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Peking University · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCarbon NanoparticlesCarbon 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 dissectionIn the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials.

Timeline

Start date
2013-12-01
Primary completion
2014-06-01
First posted
2014-04-25
Last updated
2014-04-25

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02123407. Inclusion in this directory is not an endorsement.