NCT01804998

Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy

Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Sentinel Node Biopsy	Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.
PROCEDURE	Laparoscopy Assisted Gastrectomy	In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.

Timeline

• Start date: 2013-03-27
• Primary completion: 2020-01-15
• Completion: 2021-12-21
• First posted: 2013-03-05
• Last updated: 2022-02-15

Locations

7 sites across 1 country: South Korea