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Fluorescence Image-Guided Lymphadenectomy in Robotic Gastrectomy (IG-MIG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931044
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Amilcare Parisi, International Study Group on Minimally Invasive Surgery for Gastric Cancer

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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

  2. FLNs identification rate (No, %) [ Time Frame: 1 year ]
    Patients in which the procedure detects FLNs.

  3. 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]


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931044


Contacts
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Contact: Jacopo Desiderio, MD +393497531121 j.desiderio@aospterni.it

Locations
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Italy
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       cavalied@gmail.com   
Azienda Ospedaliera di Terni "Santa Maria" - S.C. di Chirurgia Digestiva Recruiting
Terni, Italy, 05100
Contact: Jacopo Desiderio, MD    +393497531121    j.desiderio@aospetrni.it   
Sponsors and Collaborators
International Study Group on Minimally Invasive Surgery for Gastric Cancer
Publications:

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Responsible Party: Amilcare Parisi, Director of the Department of Digestive Surgery - St. Mary's Hospital of Terni, International Study Group on Minimally Invasive Surgery for Gastric Cancer
ClinicalTrials.gov Identifier: NCT03931044    
Other Study ID Numbers: IG-MIG Vers. 1.0-05.03.2019
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amilcare Parisi, International Study Group on Minimally Invasive Surgery for Gastric Cancer:
Robotic surgery
fluorescence
indocyanine green
lymphadenectomy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases