Clinical trial · Interventional
Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial
Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial (EPL Study)
NCT02140034CI-TRIAL-00014547EPLunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extensive Peritoneal Lavage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Arm: Extensive Peritoneal Lavage
- description
- The peritoneal cavity of subject will be washed with 10 liters of warmed normal saline (1 liter per cycle for 10 cycles) . The abdomen will be closed as per standard
- interventionNames
- Procedure: Extensive Peritoneal Lavage
- type
- NO_INTERVENTION
- label
- Control Arm: Standard Treatment
- description
- The peritoneal cavity of subjects will be washed with 2 liters or less of warmed normal saline. The abdomen will be closed as per standard.
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 3 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDMisawa 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. PMID 24287077
- BACKGROUNDKuramoto 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. PMID 19638909
- DERIVEDYang 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. PMID 33253659