Extensive peritoneal lavage after curative gastrectomy for gastric cancer (EXPEL): study protocol of an international multicentre randomised controlled trial

Abstract

Peritoneal recurrence after gastrectomy for gastric cancer is common and the prognosis is dismal. Recent evidence suggests that extensive peritoneal lavage with large volume of normal saline after surgery before abdominal closure can reduce the risk of peritoneal recurrence and improve overall survival. This study aims to evaluate the benefit of extensive intraoperative peritoneal lavage. This is a prospective, open-label, multicentre randomised controlled trial involving 15 international centres in China, Korea, Japan, Malaysia and Singapore. Patients with cT3/4 stomach cancer undergoing curative resection are randomised to either extensive peritoneal lavage (10 l of saline) or standard lavage (≤2 l of saline). The primary outcome is overall survival and secondary outcomes include disease-free survival and peritoneal recurrence. The minimum sample size is 600 subjects with 300 per arm completing 3 years follow-up. The data will be analysed on an intention-to-treat basis, assuming a two-sided test with a 5% level of significance.

Randomized clinical trial of extensive intraoperative peritoneal lavage versus standard treatment for resectable advanced gastric cancer (CCOG 1102 trial)

“…Detection of even a small survival benefit, which may be clinically relevant, could have been missed. Given the fact that EIPL is a safe and easy to perform intervention, an international study group recently started a large‐scale RCT, the EXPEL study, which aims to demonstrate the survival benefit of EIPL therapy after curative gastrectomy, and is including 800 patients with cT3–4 gastric cancer.…”

Dual-Energy Computed Tomography-Based Radiomics to Predict Peritoneal Metastasis in Gastric Cancer

“…For patients with PM, upfront resection is not recommended for its uncertain benefit (5). New treatment strategies, such as intraperitoneal chemotherapy and extensive intraoperative peritoneal lavage, is of improved prognosis for those patients (6)(7)(8)(9). Therefore, early and accurate detection for peritoneal metastasis is of an urgent need to adopt appropriate treatment to improve the prognosis for patients.…”

Identifying Factors Affecting Cancer-related Death in Patients with Adenocarcinoma Gastric Cancer; An Analysis in the Presence of Competing Risks

“…Kim et al (2016) investigated the effect of eradication of Helicobacter pylori on long-term survival after distal gastrectomy in patients with gastric cancer. In this study, peritoneal recurrence was considered an interest event, and local, regional, distant, and death events were considered competing events (20). In a study by Kubata et al (2014), they examined the prognostic significance of postoperative complications in gastric cancer patients.…”