Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy
Condition: Early Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric
      cancer is less invasive method which can increase quality of life. For last two years,
      multicenter quality control study (Phase II) has been performed in Korea and tolerable
      results were observed. Based on these results, multicenter phase III trial is required to
      validate the clinical role of laparoscopic sentinel lymph node biopsy.
    

Detailed description: 
      The final analyses include the modified intention to treatment analysis (full analysis set)
      and Per Protocol analysis (including patients who underwent assigned surgery without
      agreement withdrawal).

        1. Injection of tracer and sentinel basin dissection

             -  Tracer: Tc 99m HSA (Human serum albumin, 2ml, 0.1mCi/ml) + ICG (indocyanine green,
                2ml, 5mg/ml)

             -  Endoscopic injection of tracer on 4 sites around gastric cancer

             -  Identification of sentinel basin using laparoscopic probe (Neoprobe)

             -  Laparoscopic sentinel basin dissection and identification of sentinel node at back
                table

        2. Surgical considerations

             -  If positive sentinel nodes were diagnosed in frozen section, conventional
                gastrectomy is performed.

             -  If micrometastasis or isolate tumor cells in sentinel basin lymph nodes were
                diagnosed in the permanent pathology, re-operation of conventional gastrectomy is
                not performed.

             -  However, re-operation of converntional gastrectomy should be performed in case of
                macrometastasis, deep and lateral margin positive, more than pT2 lesion in the
                permanent pathology.

        3. H.pylori eradication - There was no clear evidence that H.pylori eradication reduced
           development of metachronous gastric cancer. H.pylori eradication was planned to perform
           according to physician's decision or patient's need. However, recently, the effect of
           H.pylori eradication in development of metachronous gastric cancer was published in NEJM
           (Choi et al. 2018). Therefore, from now on, H. pylori eradication will be recommended to
           enrolled patients with H.pylori.
    

Intervention name(s): Laparoscopic Sentinel Node Biopsy; Laparoscopy Assisted Gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.; In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stomach preserving surgery after laparoscopic sentinel node dissection and evaluation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laparoscopic sentinel lymph node biopsy; phase 3; early gastric cancer