NCT02123407

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

April 21, 2014

Last Update Submit

April 23, 2014

Conditions

Advanced Gastric Cancer

Keywords

Advanced Gastric CancerCarbon NanoparticlesLymph Nodes

Outcome Measures

Primary Outcomes (1)

  • the number of harvested lymph nodes

    1 day after operation

Secondary Outcomes (1)

  • the diameter of harvested lymph nodes

    1 day after operation

Study Arms (2)

Carbon Nanoparticles

EXPERIMENTAL

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

Gastrectomy with D2 dissection

ACTIVE COMPARATOR

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

Procedure: Gastrectomy with D2 dissection

Interventions

Carbon NanoparticlesDRUG

Carbon Nanoparticles will be injected into the subserosa of stomach around the tumor.Gastrectomy with D2 dissection will be performed after the injection.

Carbon Nanoparticles
Gastrectomy with D2 dissectionPROCEDURE

In the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials.

Gastrectomy with D2 dissection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically and CT confirmed resectable advanced gastric cancer
  • No prior treatment
  • No metastases

You may not qualify if:

  • Having allergic reaction
  • Pregnant
  • R0 resection is not achieved by gastrectomy with D2 lymphadenectomy according to Japanese gastric cancer treatment guidelines 2010 (ver. 3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University School of Oncology

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (4)

  • Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.

    PMID: 18669424BACKGROUND

  • Catarci M, Guadagni S, Zaraca F, Pistoia MA, Mastracchio A, Trecca A, Ruco L, Carboni M. Prospective randomized evaluation of preoperative endoscopic vital staining using CH-40 for lymph node dissection in gastric cancer. Ann Surg Oncol. 1998 Oct-Nov;5(7):580-4. doi: 10.1007/BF02303825.

    PMID: 9831104BACKGROUND

  • Okamoto K, Sawai K, Minato H, Yada H, Shirasu M, Sakakura C, Otsuji E, Kitamura K, Taniguchi H, Hagiwara A, Yamaguchi T, Takahashi T. Number and anatomical extent of lymph node metastases in gastric cancer: analysis using intra-lymph node injection of activated carbon particles (CH40). Jpn J Clin Oncol. 1999 Feb;29(2):74-7. doi: 10.1093/jjco/29.2.74.

    PMID: 10089947BACKGROUND

  • Siewert JR, Kestlmeier R, Busch R, Bottcher K, Roder JD, Muller J, Fellbaum C, Hofler H. Benefits of D2 lymph node dissection for patients with gastric cancer and pN0 and pN1 lymph node metastases. Br J Surg. 1996 Aug;83(8):1144-7. doi: 10.1002/bjs.1800830836.

    PMID: 8869330BACKGROUND

MeSH Terms

Interventions

Gastrectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Jiafu Ji, master

CONTACT

86-10-88196048dr.jijiafu@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Peking University

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 25, 2014

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

CN(1)