Clinical trial · Interventional
Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer
Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer：a Prospective Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon Nanoparticles | Drug | — | UNRESOLVED |
| Gastrectomy with D2 dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carbon Nanoparticles
- 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.
- interventionNames
- Drug: Carbon Nanoparticles
- type
- ACTIVE_COMPARATOR
- label
- Gastrectomy with D2 dissection
- description
- Gastrectomy with D2 dissection will be performed in the control arm,no Carbon Nanoparticles or other coloring materials used
- interventionNames
- Procedure: Gastrectomy with D2 dissection
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (4)
- BACKGROUNDSasako 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 18669424
- BACKGROUNDCatarci 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 9831104
- BACKGROUNDOkamoto 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 10089947
- BACKGROUNDSiewert 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 8869330