curative gastrectomy for gastric cancer study (EXPEL): An - - PowerPoint PPT Presentation

Extensive peritoneal lavage after curative gastrectomy for gastric cancer study (EXPEL): An international multicenter randomized controlled Trial

JB So, HK Yang, JF Ji, M Terashima, GX Li, SU Han, BC Tai on behalf of EXPEL Study group

Jimmy B.Y. So

Methods: Study Design

• Prospective, open-labelled, investigator-initiated, phase 3 randomised

controlled trial

Eligibility Criteria

• Gastric cancer:

cT3/4, N0-2, M0

• Curative surgery

Lavage Arm 10 Liters of normal saline Standard arm ≤2 Liters of normal saline Follow-up: 3 monthly for 1st 2 years 6 monthly for 3rd year Primary endpoint Overall survival Secondary endpoints

• 1. Disease free survival
• 2. Peritoneal recurrence

Jimmy B.Y. So

R

Results: Consort Diagram

800 patients randomised Lavage (n=398) Standard (n=402)

2 exclusions:

396 analysed

Non-compliance

• 1 received lavage

401 analysed

Non-compliance

• 2 did not receive lavage

1 exclusion:

• 55 lost to follow-up
• <= 3 months (n=1)
• 6 to 12 months (n=6)
• > 12 months (n=48)
• 44 lost to follow-up
• No follow up information
• No follow up information
• <= 3 months (n=1)
• 6 to 12 months (n=4)
• > 12 months (n=39)

Jimmy B.Y. So

Primary endpoint- Overall Survival

Conclusion

• Extensive lavage with saline did not reduce risk of

peritoneal recurrence nor improve survival after gastric cancer surgery

• It may increase risk of postoperative complications
• We do not recommend this treatment for gastric cancer

patients

Jimmy B.Y. So