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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: Carbon Nanoparticles
* Procedure: Gastrectomy with D2 dissection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon Nanoparticles<br>Carbon Nanoparticles could be used in this arm.The drug is injected into the subserosa of stomach.Injections of 1.0 ml of Carbon Nanoparticles (0.2 ml in each cardinal point adjacent to the lesion) will be performed about 10 minutes before surgery.Then,gastrectomy with D2 dissection will be performed. | Drug: Carbon Nanoparticles<br>* Carbon Nanoparticles will be injected into the subserosa of stomach around the tumor.Gastrectomy with D2 dissection will be performed after the injection.<br>|
| Active Comparator: Gastrectomy with D2 dissection<br>Gastrectomy with D2 dissection will be performed in the control arm,no Carbon Nanoparticles or other coloring materials used | Procedure: Gastrectomy with D2 dissection<br>* In the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of harvested lymph nodes |  | 1 day after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the diameter of harvested lymph nodes |  | 1 day after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Gastric Cancer, Carbon Nanoparticles, Lymph Nodes