Dual tracer navigation for lymph node dissection in laparoscopic radical gastrectomy (DANCE trial) : a protocol for a prospective, randomized clinical trial
© 2023. BioMed Central Ltd., part of Springer Nature..
BACKGROUND: Lymph node (LN) metastasis is the most common metastasis route in gastric cancer. Extensive dissection of LNs can significantly improve the prognosis of patients with gastric cancer. Recently, multiple clinical studies have demonstrated that either indocyanine green (ICG) or carbon nanoparticles (CNs) can assist to promote the dissection of LNs during laparoscopic radical gastrectomy. Considering the pros and cons of the two tracers, this study proposed a novel method of dual tracer (ICG combined with CNs) for lymphatic tracing in laparoscopic gastric cancer surgery.
METHODS: This trial is a prospective, randomized controlled trial (RCT) with an estimation of 516 participants that randomize into 4 groups (1:1:1:1), namely control group, ICG group, CNs group, and dual tracer group. The primary outcome is the number of dissected LNs. The secondary outcomes include positive rate, false positive rate, negative rate, false negative rate, number of metastatic LNs, relationship between LN metastasis and tracer stained, operation duration, blood loss, incision length, morbidity and mortality rate, 3-year DFS (disease free survival), PFS (progression-free survival), and OS (overall survival).
DISCUSSION: This study will investigate the efficacy and safety of a novel strategy using dual tracers for laparoscopic gastrectomy. The protocol has been approved by the Ethics Committee of Nanjing Drum Tower Hospital (2021-361-02). The trial findings will be published in peer-reviewed journals.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2100051309). Registered 18 September 2021, https://www.chictr.org.cn/showproj.html?proj=133764.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:24 |
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| Enthalten in: |
Trials - 24(2023), 1 vom: 02. Okt., Seite 624 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lu, Yanjun [VerfasserIn] |
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| Links: |
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| Themen: |
Carbon nanoparticles |
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| Anmerkungen: |
Date Completed 04.10.2023 Date Revised 20.11.2023 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s13063-023-07676-4 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM362799717 |
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| 520 | |a BACKGROUND: Lymph node (LN) metastasis is the most common metastasis route in gastric cancer. Extensive dissection of LNs can significantly improve the prognosis of patients with gastric cancer. Recently, multiple clinical studies have demonstrated that either indocyanine green (ICG) or carbon nanoparticles (CNs) can assist to promote the dissection of LNs during laparoscopic radical gastrectomy. Considering the pros and cons of the two tracers, this study proposed a novel method of dual tracer (ICG combined with CNs) for lymphatic tracing in laparoscopic gastric cancer surgery | ||
| 520 | |a METHODS: This trial is a prospective, randomized controlled trial (RCT) with an estimation of 516 participants that randomize into 4 groups (1:1:1:1), namely control group, ICG group, CNs group, and dual tracer group. The primary outcome is the number of dissected LNs. The secondary outcomes include positive rate, false positive rate, negative rate, false negative rate, number of metastatic LNs, relationship between LN metastasis and tracer stained, operation duration, blood loss, incision length, morbidity and mortality rate, 3-year DFS (disease free survival), PFS (progression-free survival), and OS (overall survival) | ||
| 520 | |a DISCUSSION: This study will investigate the efficacy and safety of a novel strategy using dual tracers for laparoscopic gastrectomy. The protocol has been approved by the Ethics Committee of Nanjing Drum Tower Hospital (2021-361-02). The trial findings will be published in peer-reviewed journals | ||
| 520 | |a TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2100051309). Registered 18 September 2021, https://www.chictr.org.cn/showproj.html?proj=133764 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Carbon nanoparticles | |
| 650 | 4 | |a Gastric cancer | |
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| 650 | 4 | |a Lymph node | |
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| 700 | 1 | |a Shen, Xiaofei |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Qiongyuan |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Zhiyan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Meng |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Xiaofeng |e verfasserin |4 aut | |
| 700 | 1 | |a Guan, Wenxian |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Song |e verfasserin |4 aut | |
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