Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer (SEIPLUS)
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The investigators study aims to explore the potential function of extensive intraoperative
      peritoneal lavage in improving the overall survival and progression-free survival for locally
      advanced gastric cancer after curative resection.

      Hypothesis: Overall survival and progression-free survival of locally advanced gastric cancer
      are improved by extensive intraoperative peritoneal lavage.
    

Detailed description: 
      Gastric cancer has been one of the most frequently common cancers and remains the third
      leading cause of death among malignant tumors all over the world. Surgery has always been
      considered as the most effective treatment. While significant surgical technique and
      perioperative management have dramatically improved the survival of patients with advanced
      gastric cancer, patients with T4 stage or serosal-positive gastric cancer often suffer from
      recurrence as peritoneal dissemination, and the prognosis of those patients is extremely
      poor. Despite curatively resected, Peritoneal metastasis is completed by the implantation of
      peritoneal free cancer cells exfoliated from serosa-invasive tumors. Therefore, things need
      to be done to eliminate the free exfoliated cancer cells on the peritoneal lining in order to
      reduce the risk of peritoneal recurrence.

      A multi-institutional prospective, randomized trial has been launched by Kuramoto recently.
      The trail was intended to demonstrate the superiority in overall survival of addition of
      Extensive Intraoperative peritoneal Lavage (EIPL) to standard treatment in patients with≥T3
      carcinoma of stomach. Based on the'limiting dilution theory', after total or distal
      gastrectomy with D2 lymphadenectomy, the peritoneal cavity is extensively rinsed 10 times
      with 1 L physiological saline at a time, followed by complete aspiration of the fluid. In
      total, 10 L saline is to be used. In this study, the EIPL-IPC group had a significantly lower
      incidence of peritoneal recurrence. Furthermore, the 5-year overall survival rate of the
      patients in the EIPL-IPC group (43.8%) was significantly better than that of the
      intraperitoneal chemotherapy (IPC) group (4.6%) and the surgery-alone group (0%). All in all,
      EIPL is easy to carry out, safe and inexpensive. Therefore, gastrectomy with EIPL will be a
      new standard treatment of gastric cancer.

      To ensure the quality of the study, two interim analyses will be planned at the half and the
      completion of the study respectively. The Data and Safety Monitoring Committee will
      independently review the interim analysis and stop the study ahead of schedule if necessary.
      Furthermore, to improve the study progress and quality, the in-house interim monitoring will
      be performed.
    

Intervention name(s): Extensive Intraoperative Peritoneal Lavage
Intervention type(s): Other
Intervention description(s): Extensive Intraoperative Peritoneal Lavage
Other intervention name(s): EIPL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Extensive Intraoperative Peritoneal Lavage; EIPL; Gastric Cancer