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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon Nanoparticles | Drug | Carbon Nanoparticles will be injected into the subserosa of stomach around the tumor.Gastrectomy with D2 dissection will be performed after the injection. |
| Measure | Description | Time Frame |
|---|---|---|
| the number of harvested lymph nodes | 1 day after operation |
| Measure | Description | Time Frame |
|---|---|---|
| the diameter of harvested lymph nodes | 1 day after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiafu Ji, master | Contact | 86-10-88196048 | dr.jijiafu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University School of Oncology | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18669424 | Background | 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. | |
| 9831104 | Background |
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| ID | Term |
|---|---|
| D005743 | Gastrectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Gastrectomy with D2 dissection | Procedure | In the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials. |
|
| 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. |
| 10089947 | Background | 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. |
| 8869330 | Background | 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. |