NCT03931044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

April 21, 2019

Last Update Submit

April 25, 2019

Conditions

Gastric CancerSentinel Lymph Node

Keywords

Robotic surgeryfluorescenceindocyanine greenlymphadenectomy

Outcome Measures

Primary Outcomes (3)

  • Mean difference of total number of LNs retrieved during surgery (mean±DS)

    Usefulness of the Navigation Surgery through a comparison between the two groups on the number of LNs retrieved

    1 year

  • FLNs identification rate (No, %)

    Patients in which the procedure detects FLNs.

    1 year

  • Accuracy (%; 95% CI)

    Degree of deviation between the FLNs tumor status and the status found in the other LNs analyzed. \[true positive patients + true negative patients / TOT patients\]

    1 year

Secondary Outcomes (1)

  • Mean difference of total number of LNs retrieved during the lymphadenectomy of the D2 anatomical plane (mean±DS).

    1 year

Study Arms (2)

Image-Guided Robotic Gastrectomy

EXPERIMENTAL

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

Robotic Gastrectomy

NO INTERVENTION

Data from patients undergoing the same surgery without the ICG imaging procedure will be collected during the same study period.

Interventions

Image-Guided Robotic GastrectomyPROCEDURE

The near-infrared technology, integrated in the robotic camera, will be used to detect fluorescent lymphonodes.

Image-Guided Robotic Gastrectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of gastric cancer proved through the endoscopic biopsy
  • cT1 - cT3
  • cN0

You may not qualify if:

  • history of allergies related to iodine
  • pregnancy
  • cT4,
  • cN +
  • distant metastases
  • estimated sizes \> 4cm
  • synchronous malignant tumors in other organs
  • ASA score ≥ 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedale di Forlì "G.B. Morgagni" - AUSL della Romagna - U.O.C. di Chirurgia e Terapie Oncologiche Avanzate

Forlì, 47121, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Terni "Santa Maria" - S.C. di Chirurgia Digestiva

Terni, 05100, Italy

RECRUITING

Related Publications (12)

  • Bray F, Jemal A, Grey N, Ferlay J, Forman D. Global cancer transitions according to the Human Development Index (2008-2030): a population-based study. Lancet Oncol. 2012 Aug;13(8):790-801. doi: 10.1016/S1470-2045(12)70211-5. Epub 2012 Jun 1.

    PMID: 22658655BACKGROUND

  • Hartgrink 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: 19625077BACKGROUND

  • Sasako M, McCulloch P, Kinoshita T, Maruyama K. New method to evaluate the therapeutic value of lymph node dissection for gastric cancer. Br J Surg. 1995 Mar;82(3):346-51. doi: 10.1002/bjs.1800820321.

    PMID: 7796005BACKGROUND

  • Japanese 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: 27342689BACKGROUND

  • Kitagawa 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: 11972551BACKGROUND

  • Kitagawa 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: 24019550BACKGROUND

  • Kitagawa 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.

    PMID: 15895450BACKGROUND

  • Tani T, Sonoda H, Tani M. Sentinel lymph node navigation surgery for gastric cancer: Does it really benefit the patient? World J Gastroenterol. 2016 Mar 14;22(10):2894-9. doi: 10.3748/wjg.v22.i10.2894.

    PMID: 26973385BACKGROUND

  • Vahrmeijer AL, Hutteman M, van der Vorst JR, van de Velde CJ, Frangioni JV. Image-guided cancer surgery using near-infrared fluorescence. Nat Rev Clin Oncol. 2013 Sep;10(9):507-18. doi: 10.1038/nrclinonc.2013.123. Epub 2013 Jul 23.

    PMID: 23881033BACKGROUND

  • Yoshida M, Kubota K, Kuroda J, Ohta K, Nakamura T, Saito J, Kobayashi M, Sato T, Beck Y, Kitagawa Y, Kitajima M. Indocyanine green injection for detecting sentinel nodes using color fluorescence camera in the laparoscopy-assisted gastrectomy. J Gastroenterol Hepatol. 2012 Apr;27 Suppl 3:29-33. doi: 10.1111/j.1440-1746.2012.07067.x.

    PMID: 22486868BACKGROUND

  • Bu L, Shen B, Cheng Z. Fluorescent imaging of cancerous tissues for targeted surgery. Adv Drug Deliv Rev. 2014 Sep 30;76:21-38. doi: 10.1016/j.addr.2014.07.008. Epub 2014 Jul 24.

    PMID: 25064553BACKGROUND

  • Marano A, Priora F, Lenti LM, Ravazzoni F, Quarati R, Spinoglio G. Application of fluorescence in robotic general surgery: review of the literature and state of the art. World J Surg. 2013 Dec;37(12):2800-11. doi: 10.1007/s00268-013-2066-x.

    PMID: 23645129BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Jacopo Desiderio, MD

CONTACT

+393497531121j.desiderio@aospterni.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Digestive Surgery - St. Mary's Hospital of Terni

Study Record Dates

First Submitted

April 21, 2019

First Posted

April 29, 2019

Study Start

April 1, 2019

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

IT(2)