Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

Overview

Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2014

Interventions

  • Procedure: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy
    • 0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy

Arms, Groups and Cohorts

  • Experimental: NIR with ICG group

Clinical Trial Outcome Measures

Primary Measures

  • To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging
    • Time Frame: About 7 days after operation when pathologic result was reported

Participating in This Clinical Trial

Inclusion Criteria

1. Males or Females, aged≥20 years and ≤80 years 2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry 3. American Society of Anesthesiolosists (ASA) score of 1 to 3 4. Histologically confirmed adenocarcinoma in stomach 5. Clinical stage I (T1N0M0, T2N0M0, T1N1M0) 5. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study Exclusion Criteria:

1. M1 status 2. Experience of previous gastric resection 3. Complication due to gastric cancer, such as complete obstruction or perforation 4. History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer 5. History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Provider of Information About this Clinical Study
    • Sponsor

References

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Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecol Oncol. 2012 Jan;124(1):78-82. doi: 10.1016/j.ygyno.2011.09.025. Epub 2011 Oct 11.

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Koyama T, Tsubota A, Nariai K, Mitsunaga M, Yanaga K, Takahashi H. Novel biomedical imaging approach for detection of sentinel nodes in an experimental model of gastric cancer. Br J Surg. 2007 Aug;94(8):996-1001.

Jeschke S, Lusuardi L, Myatt A, Hruby S, Pirich C, Janetschek G. Visualisation of the lymph node pathway in real time by laparoscopic radioisotope- and fluorescence-guided sentinel lymph node dissection in prostate cancer staging. Urology. 2012 Nov;80(5):1080-6. doi: 10.1016/j.urology.2012.05.050. Epub 2012 Sep 15.

Cahill RA, Anderson M, Wang LM, Lindsey I, Cunningham C, Mortensen NJ. Near-infrared (NIR) laparoscopy for intraoperative lymphatic road-mapping and sentinel node identification during definitive surgical resection of early-stage colorectal neoplasia. Surg Endosc. 2012 Jan;26(1):197-204. doi: 10.1007/s00464-011-1854-3. Epub 2011 Aug 19.

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