Extensive peritoneal lavage after curative gastrectomy for gastric cancer (EXPEL): study protocol of an international multicentre randomised controlled trial.
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.
Department of Surgery, University Surgical Cluster, National University Health System, Singapore.
Guowei
G
Kim
Department of Surgery, University Surgical Cluster, National University Health System, Singapore.
Elya
E
Chen
Department of Surgery, University Surgical Cluster, National University Health System, Singapore.
Amy Yl
AY
Tay
Department of Surgery, University Surgical Cluster, National University Health System, Singapore.
Jin San
JS
Lee
Department of Surgery, University Surgical Cluster, National University Health System, Singapore.
Janelle Ns
JN
Phua
Department of Surgery, University Surgical Cluster, National University Health System, Singapore.
Asim
A
Shabbir
Department of Surgery, University Surgical Cluster, National University Health System, Singapore.
Jimmy By
JB
So
Saw Swee Hock School of Public Health, National University of Singapore, Singapore.|Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Bee Choo
BC
Tai
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018572:Disease-Free Survival; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010533:Peritoneal Lavage / Q000379:methods*; D011379:Prognosis; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D055815:Young Adult
extensive peritoneal lavage; gastrectomy; gastric cancer; randomised control trial; protocol