Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial

Gastric Cancer Clinical Trial

— EPL  

Official title:

Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial (EPL Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02140034
• Other study ID #: EPL Study
• Secondary ID: 2013/00172
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 15, 2014
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2014
• Source: National University Hospital, Singapore
• Contact: Jimmy So, MBChB
• Phone: +65 6772 5555
• Email: sursbyj[@]nus.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Extensive Peritoneal Lavage

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		3 years	No
Secondary	Disease Free Survival		3 years	No
Secondary	Peritoneal Recurrence Rate		3 years	No