Clinical Study on Laparoscopic Gastrectomy for Early Gastric Cancer (COACT_0301)
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the
      stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With
      the increasing tendency toward minimally invasive surgery, there has been an effort to apply
      minimally invasive techniques to the treatment of EGC. Laparoendoluminal mucosectomy and
      lesion-lifting gastric wedge resection have been developed for this purpose. However, these
      methods have the disadvantage of limited indications according to the size, shape and depth
      of invasion. Kitano et al. performed the first laparoscopy-assisted subtotal gastrectomy with
      lymph node dissection and manual anastomosis with anterior wall lifting method for a patient
      with EGC. In 1995, Uyama et al. and Nagai et al. performed laparoscopy-assisted subtotal
      gastrectomy with lymph node dissections using an automatic stapler instead of manual
      anastomosis for the gastroduodenal anastomosis. It has been possible to maintain an adequate
      distance from the lesion to the proximal and distal margins of resection, to perform radical
      lymph node dissection, and to achieve excellent postoperative recovery. However, there is a
      very limited evidence of superiority of laparoscopic gastrectomy over open surgery. There is
      only one interim report of randomized clinical trial of comparing laparoscopic gastrectomy
      and open gastrectomy. A well-designed clinical study to prove the benefit and safety is
      definitely needed Objective: to compare Laparoscopy - assisted Distal Gastrectomy (LADG) with
      Open Distal Gastrectomy (ODG) in terms of survival, recovery, pain, complications, and
      quality of life (QOL) Hypothesis: LADG is beneficial in QOL, pain, recovery, complications
      while maintaining equivalent survival with ODG
    

Detailed description: 
      1. Randomization

           Randomization is done by person who is not involved in study. So it is done by the
           person in Center for Clinical Trial in National Cancer Center. The patient is enrolled
           in the out-patient clinic after getting informed consent of the clinical study from the
           patient. Surgeon factor is not considered as a randomization factor because this
           clinical study will be performed intramurally. In Center for Gastric Cancer, National
           Cancer Center, Surgical techniques and extent of resections are generally standardized
           and surgical outcomes are same in terms of complication and recovery.

        2. Follow-up schedule

           Patients are followed up in the outpatient department at four weeks, three months, six
           months, and twelve months after the operation, and every six months thereafter. On each
           visit, history was reviewed and physical examination was done. A complete blood count
           (CBC) and serum chemistry were evaluated also. An esophago-gastro-duodenoscopy (EGD) was
           performed at three months after the operation and yearly thereafter. Abdominal computed
           tomography (ACT) was evaluated annually.

        3. Assessment of QOL The European EORTC QLQ-C30 (version 3.0) questionnaire is a 30-item
           cancer-specific integrated system for assessing the health-related QOL of cancer
           patients. The questionnaire incorporates five scales of function (physical, role,
           cognitive, emotional and social), three symptom scales (fatigue, pain and nausea and
           vomiting), a global health and QOL scale, and single items for the assessment of
           additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss,
           sleep disturbance, constipation and diarrhea), as well as the perceived financial impact
           of the disease and treatment. All items were scored on four-point Likert scales, with
           the exception of two items in the global health QOL scale, which used modified
           seven-point linear analog scales. The EORTC QLQ-STO22 with a 22-item stomach
           cancer-specific questionnaire was also used. It incorporates five hypothesized
           scales-(dysphasia, eating restrictions, pain, reflux and anxiety) and four single items
           (having a dry mouth, body image, taste, and hair loss) covering disease and
           treatment-related symptoms and specific emotional consequences of gastric cancer.12 All
           instruments of the questionnaire were administered preoperatively and postoperatively at
           seven days, 30 days, 90 days and yearly. Those time points were chosen at usual
           follow-up schedule for every gastrectomized patients in our institute, to maximize
           compliance for the questionnaire, and to compare other parameters at the same time.

        4. Statistical analyses The EORTC QLQ-C30 symptom subscale and the EORTC QLQ-STO22 subscale
           scores are reported using a scale from 0 to 100. Statistical analyses of the QOL
           outcomes evaluated the differences between the LADG and the ODG groups with respect to
           the overall changes from the preoperative scores (baseline) to those obtained at
           follow-up. To adjust for possible baseline differences, we included the baseline values
           in the model. All comparisons between groups were based on 'intent-to-treat' analyses in
           which patients were analyzed according to their assigned treatment group. Categorical
           variables were compared using the χ2 test, and continuous variables were analyzed using
           the Student's t-test. Analysis of Covariance (ANCOVA) with repeated measures was used to
           compare the two groups of patients with respect to overall changes in their short term
           quality of life after the surgery. The SAS (SAS Institute Inc., Cary, NC, USA) program
           called 'PROC GLM' was used.
    

Intervention name(s): laparoscopy assisted distal gastrectomy; Open distal gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): under general endotracheal anesthesia, Five laparoscopic ports are made. Lymph node dissection and ligations of vessels are done in laparoscopic field. A 5-6cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, stomach is taken out and resected. A Billroth I gastroduodenostomy using EEA stapler and GIA is performed. Abdomen is closed after hemostasis.; Open distal gastrectomy is performed under general endotracheal anesthesia. A long midline incision is made. omentectomy is skipped and D2 lymph node dissection is performed. Anastomosis is done in same manner as LADG. Abdomen is closed after hemostasis
Other intervention name(s): LADG; ODG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stomach cancer; laparoscopy; gastrectomy; QOL; survival; clinical study