Efficacy of Laparoscopic Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      -  It was confirmed that the laparoscopic surgery decreases the postoperative pain and
           reduces the recovery periods in the various surgical fields such as cholecystectomy and
           colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is
           applicable to malignant tumor according to the development of surgical techniques and
           medical instruments.

        -  In case of early stage of gastric cancer, as the diverse clinical evidences, the
           gastrectomy has been commonly applied, however, the opening surgery is still applied for
           advanced gastric cancer due to lack of clinical evidence.

        -  In Korea, approximately 38% of patients who undergo surgery for gastric cancer are
           diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer
           registration business in 2009). There are various clinical evidences to apply
           laparoscopic surgery to the patients, however, most of them are retrospective or cohort
           study results.

        -  For the clinical application of surgical treatment regarding locally advanced gastric
           cancer using laparoscopic surgical technique, it requires the confirmation of definite
           execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of
           surgery and oncological usefulness should be verified.

        -  In order for this, it is only possible to confirm through the comparison of short-term
           surgical results (complications, mortalities, operative time and duration of
           hospitalization etc) and long-term results (survival rates and recurrence rates etc)
           between laparoscopic surgery and opening surgery based on the multicenter large-sized
           randomized prospective study with current standard treatment.
    

Detailed description: 
      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 Relapse 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.
    

Intervention name(s): Laparoscopic gastrectomy; Open gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): After laparoscopic observation, the possibility of surgery can be considered by examining inside of abdomen.
The surgeon undergoes laparoscopic subtotal gastrectomy and D2 lymph node dissection
After lymph node dissection, it is possible to undergo gastrectomy on appropriate part and reconstruction under small incision or laparoscopic view.
As the reconstruction, one of the techniques like Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.; After laparotomy, the possibility of surgery can be considered by examining inside of abdomen.
The surgeon undergoes open subtotal gastrectomy and D2 lymph node dissection
After lymph node dissection, one of the techniques likes Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.
Other intervention name(s): Group A; LDG; Group B; ODG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach neoplasm; Laparoscopy