Clinical trial · Interventional
Fluorescence Image-Guided Lymphadenectomy in Robotic Gastrectomy
Fluorescence Image-Guided Lymphadenectomy Using Indocyanine Green and Near Infrared Technology in Robotic Gastrectomy
- 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)
Gastric cancer is a worldwide challenge due to its spread, even epidemic in some areas, and the high mortality rates. Lymphadenectomy is considered the fundamental step during radical gastrectomy. In recent years, some researchers have tried to find a way to improve the surgical identification of the lymphatic drainage routes and lymph node stations. This new surgical frontier is the so called "navigation surgery". Among the different reported solutions, lately, the indocyanine green (ICG) has drawn attention. It is a fluorescence dye, that can be detected in the near infrared spectral band (NIR). The development of specific fluorescence imaging devices has allowed surgeons to visualize tumors, vascular and lymphatic structures. The Da Vinci Xi robotic system has an integrated imaging technology that has been used in colo-rectal and hepato-biliary surgery. However, up to date, the combined use of fluorescence imaging and robotic technology has not been evaluated during lymphadenectomy in gastric cancer. The general design of the present study is to evaluate the role of fluorescence imaging during robotic lymphadenectomy for gastric cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image-Guided Robotic Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Image-Guided Robotic Gastrectomy
- description
- The day before surgery, the ICG will be injected endoscopically into the submucosa of the four quadrants around the tumor (1.25mg/mL, 0.6mL x 4). A modified total D2 gastrectomy - including the following lymph node stations: 1 - 7 + 8a, 9, 11p, 12a - will be performed in each patient. The lymph node dissection will be performed using the Da Vinci Xi robotic system and the assistance of the near infrared technology to detect ICG fluorescence. Even the resulting fluorescent lymph nodes outside the standard dissection plane will be retrieved. The lymph node stations will be sent to the pathologist in different containers and further subdivided according to fluorescence.
- interventionNames
- Procedure: Image-Guided Robotic Gastrectomy
- type
- NO_INTERVENTION
- label
- Robotic Gastrectomy
- description
- Data from patients undergoing the same surgery without the ICG imaging procedure will be collected during the same study period.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * diagnosis of gastric cancer proved through the endoscopic biopsy * cT1 - cT3 * cN0 Exclusion Criteria: * history of allergies related to iodine * pregnancy * cT4, * cN + * distant metastases * estimated sizes \> 4cm * synchronous malignant tumors in other organs * ASA score ≥ 4
References
Publications (12)
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- BACKGROUNDHartgrink HH, Jansen EP, van Grieken NC, van de Velde CJ. Gastric cancer. Lancet. 2009 Aug 8;374(9688):477-90. doi: 10.1016/S0140-6736(09)60617-6. Epub 2009 Jul 20. PMID 19625077
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- BACKGROUNDJapanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available. PMID 27342689
- BACKGROUNDKitagawa Y, Fujii H, Mukai M, Kubota T, Otani Y, Kitajima M. Radio-guided sentinel node detection for gastric cancer. Br J Surg. 2002 May;89(5):604-8. doi: 10.1046/j.1365-2168.2002.02065.x. PMID 11972551
- BACKGROUNDKitagawa Y, Takeuchi H, Takagi Y, Natsugoe S, Terashima M, Murakami N, Fujimura T, Tsujimoto H, Hayashi H, Yoshimizu N, Takagane A, Mohri Y, Nabeshima K, Uenosono Y, Kinami S, Sakamoto J, Morita S, Aikou T, Miwa K, Kitajima M. Sentinel node mapping for gastric cancer: a prospective multicenter trial in Japan. J Clin Oncol. 2013 Oct 10;31(29):3704-10. doi: 10.1200/JCO.2013.50.3789. Epub 2013 Sep 9. PMID 24019550
- BACKGROUNDKitagawa Y, Fujii H, Kumai K, Kubota T, Otani Y, Saikawa Y, Yoshida M, Kubo A, Kitajima M. Recent advances in sentinel node navigation for gastric cancer: a paradigm shift of surgical management. J Surg Oncol. 2005 Jun 1;90(3):147-51; discussion 151-2. doi: 10.1002/jso.20220.