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

Phase 3

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Carbon Nanoparticles; Procedure: Gastrectomy with D2 dissection

• Registration Number: NCT02123407
• Lead Sponsor: Peking University

Brief 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.

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-04
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-23
• Last Update Submitted: 2014-04-23
• Study First Posted: 2014-04-25
• Last Update Posted: 2014-04-25
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the number of harvested lymph nodes	1 day after operation

Secondary Outcome Measures

Name	Time	Method
the diameter of harvested lymph nodes	1 day after operation

Trial Locations

Locations (1)

Peking University School of Oncology; 🇨🇳 Beijing, Beijing, China