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Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Phase 2
20 Years
80 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early
gastric cancer.

Laparoscopic SNNS:

1. ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative

2. Sentinel node basin identification and dissection

3. Sentinel nodes picking in back table

4. Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry
for cytokeratin)

5. If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be
performed or if positive, radical D2 gastrectomy will be performed.

Sample size: 100 cases

Study duration: 5 years( 2year enrollment, 3 year follow-up)

Inclusion Criteria:

- Age 20-80

- Informed consent

- No other malignancies

- cT1N0 stage gastric cancers < 4cm

- no allergic history of isotope

Exclusion Criteria:

- Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3 Year disease free survival

Outcome Description:

Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.

Outcome Time Frame:

Postoperative 3 year

Safety Issue:


Principal Investigator

Hyung-Ho Kim, M.D.Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital


Korea: Ministry for Health, Welfare and Family Affairs

Study ID:




Start Date:

July 2010

Completion Date:

June 2015

Related Keywords:

  • Gastric Cancer
  • Gastric cancer
  • Sentinel node navigation surgery
  • Dual method
  • Recurrence
  • Stomach Neoplasms