Fluorescence Image-Guided Lymphadenectomy in Robotic Gastrectomy (IG-MIG)
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|ClinicalTrials.gov Identifier: NCT03931044|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Sentinel Lymph Node||Procedure: Image-Guided Robotic Gastrectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fluorescence Image-Guided Lymphadenectomy Using Indocyanine Green and Near Infrared Technology in Robotic Gastrectomy|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Image-Guided Robotic Gastrectomy
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.
Procedure: Image-Guided Robotic Gastrectomy
The near-infrared technology, integrated in the robotic camera, will be used to detect fluorescent lymphonodes.
No Intervention: Robotic Gastrectomy
Data from patients undergoing the same surgery without the ICG imaging procedure will be collected during the same study period.
- Mean difference of total number of LNs retrieved during surgery (mean±DS) [ Time Frame: 1 year ]Usefulness of the Navigation Surgery through a comparison between the two groups on the number of LNs retrieved
- FLNs identification rate (No, %) [ Time Frame: 1 year ]Patients in which the procedure detects FLNs.
- Accuracy (%; 95% CI) [ Time Frame: 1 year ]Degree of deviation between the FLNs tumor status and the status found in the other LNs analyzed. [true positive patients + true negative patients / TOT patients]
- Mean difference of total number of LNs retrieved during the lymphadenectomy of the D2 anatomical plane (mean±DS). [ Time Frame: 1 year ]Impact on the D2 lymph node dissection through a comparison between the two groups on the number of LNs removed in the D2 anatomical plane.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931044
|Contact: Jacopo Desiderio, MDfirstname.lastname@example.org|
|Ospedale di Forlì "G.B. Morgagni" - AUSL della Romagna - U.O.C. di Chirurgia e Terapie Oncologiche Avanzate||Not yet recruiting|
|Forlì, Italy, 47121|
|Contact: Davide Cavaliere, MD email@example.com|
|Azienda Ospedaliera di Terni "Santa Maria" - S.C. di Chirurgia Digestiva||Recruiting|
|Terni, Italy, 05100|
|Contact: Jacopo Desiderio, MD +393497531121 firstname.lastname@example.org|