Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer
Conditions
Advanced Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Advanced Gastric Cancer, Carbon Nanoparticles, Lymph Nodes
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carbon Nanoparticles Type: Drug
Name: Gastrectomy with D2 dissection Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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)
Location
Peking University School of Oncology
Beijing, Beijing, China
Status: Recruiting
Contact: Jiafu Ji, master - 86-10-88196048 - dr.jijiafu@gmail.com
Start Date
December 2013
Sponsors
Peking University
Source
Peking University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page