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The purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer
Da Vinci robot surgery XI system has fluorescence imaging function, which can realize indocyanine green lymph node tracking navigation technology in the operation. At the same time, the lymph node tracking effect of nano carbon suspension injection is not affected by equipment. The flexible mechanical arm of Da Vinci robot combined with the application of lymph node tracing technology makes the lymph node dissection of gastric cancer surgery more thorough, and also reduces the difficulty of surgery. Indocyanine green navigational lymphadenectomy can also be performed by fluorescence laparoscopy. By comparing the two tracer techniques, the lymph node tracer technique which is more suitable for robot or laparoscopic surgery system is selected to provide help and choice for clinical surgeons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon nanoparticle suspension injection (CNSI) group | Experimental | CNSI (50 mg/dose) was produced by Chongqing Lesmei Pharmaceutical Co., Ltd.: Carbon nanoparticles were marked in the endoscopy division 1 day before surgery, and CNSI was injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.25 ml. |
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| Indocyanine green (ICG) group | Active Comparator | ICG (25 mg/dose) was produced by Dandong Yichuang Pharmaceutical. ICG was marked in the endoscopy division 1 day before surgery and injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.5 ml. Both procedures were performed by a designated medical practitioner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon nanoparticles | Drug | Endoscopic injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Retrieved Lymph Nodes | Compare total number of retrieved lymph nodes in both group. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of black-stained/fluorescence | The number of black-stained/fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group | 10 days |
| Positive rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qun Zhao | Departments of Third Surgery, Fourth Hospital of Hebei Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fourth Affiliated Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38954670 | Derived | Tian Y, Pang Y, Yang P, Guo S, Ma W, Guo H, Liu Y, Zhang Z, Ding P, Zheng T, Li Y, Fan L, Zhang Z, Wang D, Zhao X, Tan B, Liu Y, Zhao Q. Effect of carbon nanoparticle suspension injection versus indocyanine green tracer in guiding lymph node dissection during radical gastrectomy (FUTURE-01): a randomized clinical trial. Int J Surg. 2025 Jan 1;111(1):609-616. doi: 10.1097/JS9.0000000000001873. | |
| 36686792 |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Indocyanine green | Drug | Endoscopic injection |
|
|
The number of positive lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group
| 10 days |
| False positive rate | The number of negative lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group | 10 days |
| Negative rate | The number of negative lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group | 10 days |
| False negative rate | The number of positive lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group | 10 days |
| Number of Metastasis Lymph Nodes | Compare number of positive lymph nodes in both group. | 10 days |
| Morbidity and mortality rates | This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery. | 30 days |
| 3-year disease free survival rate | Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free. | 36 months |
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. | 36 months |
| Intraoperative blood loss | Intraoperative blood loss | 1 day |
| Postoperative lymph node anatomy duration | Postoperative lymph node anatomy duration | 1 day |
| Derived |
| Tian Y, Pang Y, Yang P, Guo H, Liu Y, Zhang Z, Ding P, Zheng T, Li Y, Fan L, Zhang Z, Zhao X, Tan B, Wang D, Zhao Q. The safety and efficacy of carbon nanoparticle suspension injection versus indocyanine green tracer-guided lymph node dissection during radical gastrectomy (FUTURE-01): A single-center randomized controlled trial protocol. Front Oncol. 2023 Jan 6;12:1044854. doi: 10.3389/fonc.2022.1044854. eCollection 2022. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |