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Fluorescence Image-Guided Lymphadenectomy in Robotic Gastrectomy

NCT03931044 · International Study Group on Minimally Invasive Surgery for Gastric Cancer · Updated 29 April 2019

What is being tested
Image-Guided Robotic Gastrectomy
For
Gastric Cancer; Sentinel Lymph Node
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Not stated. About 40 people. The full rules are on the registry page.
Where
Italy (2 sites)
When
Starts or started April 2019, ends June 2020. Registered 29 April 2019.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT03931044

Sites

  • Ospedale di Forlì "G.B. Morgagni" - AUSL della Romagna - U.O.C. di Chirurgia e Terapie Oncologiche AvanzateForlì, Italy
  • Azienda Ospedaliera di Terni "Santa Maria" - S.C. di Chirurgia DigestivaTerni, Italy