Trial Information

Prospective Multicenter Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer

Participating Surgeons

- Prior to this clinical trial, only the surgeons who are considered to have the
standardization by participating the assignment entitled with "KLASS-02-QC:
Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02
Trial"(ClinicalTrials.gov No: NCT01283893).

Patients Registration

- It is required to ensure that the patients meet the inclusion criteria for this
clinical trial, are free from any items of exclusion criteria, are explained about the
participation in the clinical trial along with the informed consent forms.

- After rechecking the patients with the registration check list by accessing the
web-based randomized program provided from Ajou University clinical trial center.

Randomization

- The registration randomization should be done with 1:1 ratio for each researcher.

- Baseline number (BN) should be provided to the subjects in the order of acquisition of
informed consent form. Based on the subjects who are selected as the appropriate
subjects in the end, the allocation number (AN) shall be provided in the order of
randomized allocation table.

Procedure

- Operations are performed according to the allocated group.

Adjuvant Treatment

- If it is under Stage II and Stage III in the final postoperative pathology, the
adjuvant chemotherapy based on 5-FU.

Evaluation of efficacy and safety

- 3-year disease free survival rate and overall survival rate of the patients who undergo
laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.

- Analysis of recovery after laparoscopic and open subtotal gastrectomy and D2 lymph node
dissection.

- Postoperative complications of the patients who undergo laparoscopic and open subtotal
gastrectomy and D2 lymph node dissection within postoperative 3 weeks and later.

- The quality of life at preoperative, postoperative 25 days and 1 years using recovery
index such as recovery of postoperative intestinal hypermotility, meals and duration of
hospitalization, EORTC-C30 and STO22 questionnaire between the patients who underwent
laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.