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

Peking University

Status and phase: Unknown; Phase 3

Conditions: Advanced Gastric Cancer

Treatments: Drug: Carbon Nanoparticles; Procedure: Gastrectomy with D2 dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT02123407

CA2014001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Carbon Nanoparticles

Experimental group

Description:

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.

Treatment:

Drug: Carbon Nanoparticles

Gastrectomy with D2 dissection

Active Comparator group

Description:

Gastrectomy with D2 dissection will be performed in the control arm,no Carbon Nanoparticles or other coloring materials used

Treatment:

Procedure: Gastrectomy with D2 dissection