Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy
      (LTG) and open total gastrectomy (OTG) in patients with clinical stage I
      (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the
      early operative morbidity and mortality and determine the safety of LTG compared with OTG for
      clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery
      course and compare the postoperative hospital stay of the patients enrolled in this study.
    

Detailed description: 
      Gastric cancer is an important health problem, being the fourth most common cancer and the
      third leading cause of cancer-related death worldwide. Age standardized mortality rates for
      gastric cancer are 14.3 per 100 000 in men and 6.9 per 100 000 in women. Incidence shows
      clear regional and sex variations-rates are highest in Eastern Asia, Eastern Europe, and
      South America and lowest in Northern and Southern Africa. More than 679 000 new cases and
      498,000 deaths occur every year in China, and an increasing trend of proximal gastric cancer
      is observed during the past years.

      More than 20 years after the introduction of laparoscopic gastrectomy, many large-scale
      randomized controlled trials have been conducted in Japan (JCOG0912 and JLSSG0901), Korea
      (KLASS01 and KLASS02), and China (CLASS01). These trials are all designed to evaluate the
      non-inferiority of laparoscopic-assisted distal gastrectomy (LADG) to its open counterpart.
      No RCT for laparoscopic total gastrectomy (LTG) exists at this moment. The standardization of
      techniques for esophagojejunal anastomosis in LTG has been difficult even for experienced
      surgeons.

      At present, Japan (JCOG1401), Korea (KLASS03), and Netherlands (STOMACH) have planned or
      launched clinical studies on LTG. China is one of the countries with the highest incidence of
      gastric cancer and surgeons have accumulated extensive experience through CLASS01 study. So,
      it's time for conducting the clinical research on the safety of LTG for gastric cancer.

      This CLASS02-01 trial is a prospective, multicenter trial for LTG and open total gastrectomy
      (OTG) in patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary
      purpose of this study is to evaluate the early operative morbidity and mortality and
      determine the safety of LTG compared with OTG for clinical stage I gastric adenocarcinoma.
      The second purpose is to evaluate the recovery course and compare the postoperative hospital
      stay of the patients enrolled in this study.
    

Intervention name(s): Laparoscopic total gastrectomy; Open total gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma; OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
Other intervention name(s): Study group (LTG); Control group (OTG)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; Laparoscopic total gastrectomy; Open total gastrectomy