Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in this arm

Conventional procedure is laparoscopy assisted gastrectomy in early gastric cancer patient.

Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.

Laparoscopic Sentinel Node Biopsy

In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.

Laparoscopy Assisted Gastrectomy

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.

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.

Stomach preserving surgery after laparoscopic sentinel node dissection and evaluation

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

We will discuss this topic in the research meeting later.

A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.

We will collect morbidity and mortality data for postoperative 30 days. Therefore, this end point will be completed one month later from when the last enrolled patients underwent intervention.

Survey for quality of life will be performed regularly for three years after surgery. Measurement tool is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22. In EORTC QLQ C30, there are 1 global health status scale, 5 functonal scales, and 9 symptom scales/items. EORTC QLQ STO22 includes 5 symptom scales and 4 single items. Each scale and item ranges 0 to 100. Higher score of global health status and functinoal scales indicate better quality of life and lower score of symptom scales indicates better quality of life. There is no summed score in these questionnaires.

A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention

A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy	NCT01804998	Early Gastric C...	Laparoscopic Se... Laparoscopy Ass...	20 Years - 80 Years	National Cancer Center, Korea
Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy	NCT01804998	Early Gastric C...	Laparoscopic Se... Laparoscopy Ass...	20 Years - 80 Years	National Cancer Center, Korea

Spots Global Cancer Trial Database for laparoscopic sentinel node biopsy