Clinical trial NCT02140034: Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial
Official title: Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial (EPL Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: Extensive Peritoneal Lavage
Overall Survival
Disease Free Survival
Peritoneal Recurrence Rate
T3 and T4 Gastric Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is carried out to determine the merit and reliability of extensive intraoperative peritoneal lavage as a preventive strategy

Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk of peritoneal recurrence

Detailed description: Gastric cancer is the second most common cause of cancer death worldwide. Surgery is the mainstay treatment for cure. Peritoneum is a common site of recurrence and the prognosis in patients with peritoneal recurrence is dismal. Hence, prevention is essential to patient's outcomes. In patients with serosal invasion, about half experience peritoneal recurrence within first 2 years after surgery, even after curative surgery. Peritoneal metastasis is caused by the implantation of free cancer cells in the peritoneal cavity exfoliated from the primary tumor before or during curative surgery. It is well known that cancer cells spillage could occur during surgery due to manipulation or even after lymph node dissection. If we can remove these free exfoliated cancer cells on the peritoneal lining, we may reduce the risk of tumor recurrence.

Recently, a study has demonstrated a dramatic reduction of peritoneal recurrence with extensive peritoneal lavage (EPL) in patients who underwent curative resection of gastric cancer. EPL was performed after the curative operation . The peritoneal cavity was washed with normal saline which is then followed by the complete aspiration of the fluid. This procedure was done 10 times using 1 liter of normal saline. The method was based on the 'limiting dilution theory' in which the method can dilute the number of free cancer cells to minimal hence reduce the risk of tumor implantation. In this study, among patients with microscopic peritoneal metastasis, peritoneal recurrence developed in 40% of patients with EPL and surgery, compared to 89.7% in patients with surgery alone. EPL carries minimal risk to patients. It is simple and inexpensive, and it is not time consuming. Hence, it may be an effective strategy for treatment of gastric cancer.

Eligibility criteria: Inclusion Criteria:

* Patients who have T3 (subserosal) or T4 (serosal) disease based on CT scan and intra-operative inspection with any N staging and M0 gastric cancer.
* Patients planned for open or laparoscopic gastrectomy.
* Patients undergoing gastrectomy with curative intent.
* Lower age limit of research subjects 21 years old and upper age limit of 80 years old.
* Ability to provide informed consent

Exclusion Criteria:

* Patients who undergo a palliative gastrectomy.
* Patients who undergo a gastrectomy as emergency.
* Vulnerable persons under age of 21.
* Patients receiving neoadjuvant therapy.
* Patients presented with life-threatening bleeding from tumour
* ASA score of 4 \& 5
* Patients with another primary cancer within last 5 years
* Patients with gross peritoneal and liver metastasis at surgery.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 3 years
measure: Peritoneal Recurrence Rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Jimmy So, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Misawa K, Mochizuki Y, Ohashi N, Matsui T, Nakayama H, Tsuboi K, Sakai M, Ito S, Morita S, Kodera Y. A randomized phase III trial exploring the prognostic value of extensive intraoperative peritoneal lavage in addition to standard treatment for resectable advanced gastric cancer: CCOG 1102 study. Jpn J Clin Oncol. 2014 Jan;44(1):101-3. doi: 10.1093/jjco/hyt157. Epub 2013 Nov 27.
citation: Kuramoto M, Shimada S, Ikeshima S, Matsuo A, Yagi Y, Matsuda M, Yonemura Y, Baba H. Extensive intraoperative peritoneal lavage as a standard prophylactic strategy for peritoneal recurrence in patients with gastric carcinoma. Ann Surg. 2009 Aug;250(2):242-6. doi: 10.1097/SLA.0b013e3181b0c80e.
citation: Yang HK, Ji J, Han SU, Terashima M, Li G, Kim HH, Law S, Shabbir A, Song KY, Hyung WJ, Kosai NR, Kono K, Misawa K, Yabusaki H, Kinoshita T, Lau PC, Kim YW, Rao JR, Ng E, Yamada T, Yoshida K, Park DJ, Tai BC, So JBY; EXPEL study group. Extensive peritoneal lavage with saline after curative gastrectomy for gastric cancer (EXPEL): a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):120-127. doi: 10.1016/S2468-1253(20)30315-0. Epub 2020 Nov 27.