Clinical trial · Interventional
Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer (SEIPLUS)
A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Investigation the Value of Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer
NCT02745509CI-TRIAL-00037209SEIPLUScompletedN/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)
The investigators study aims to explore the potential function of extensive intraoperative peritoneal lavage in improving the overall survival and progression-free survival for locally advanced gastric cancer after curative resection. Hypothesis: Overall survival and progression-free survival of locally advanced gastric cancer are improved by extensive intraoperative peritoneal lavage.
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 Intraoperative Peritoneal Lavage | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Extensive Intraoperative Peritoneal Lavage
- description
- Gastrectomy with D2 lymphadenectomy is performed. The peritoneal cavity of subject will be washed with 10 liters of warmed normal saline (1 liter per cycle for 10 cycles), followed by complete aspiration of the fluid . The abdomen will be closed as per standard.
- interventionNames
- Other: Extensive Intraoperative Peritoneal Lavage
- type
- NO_INTERVENTION
- label
- Standard Treatment
- description
- Gastrectomy with D2 lymphadenectomy is performed. The peritoneal lavage will be done \< 3 cycles with 3 liters or less of warmed normal saline. The abdomen will be closed as per standard.
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
2. ECOG score standard (ECOG）performance status of 0 or 1 and expected to survive more than 6 months.
3. Without any other malignancies.
4. Written informed consent from the patient.
5. Histologically proven primary gastric adenocarcinoma.
6. Patients planned for open gastrectomy.
7. Patients who have T3 (subserosal) or T4 (serosal) disease based on Ultrasound gastroscopy and intra-operative inspection with any N staging and M0 gastric cancer.
8. No preoperative neoadjuvant chemotherapy.
9. Length of esophageal invasion≤3cm and no need of thoracotomy for resection.
10. Intraoperative inclusion criteria:
1. Clinically T3, T4a or T4b.
2. Clinically H0 and M0. No peritoneal dissemination or Distant metastases.
3. Possible for R0 surgery.
Exclusion Criteria:
1. Female in pregnancy or lactation.
2. Supraclavicular lymph nodes metastases，pelvis or ovarian implantation，peritoneal dissemination，liver，lung and bone metastases.
3. Massive ascites or cachexia.
4. Patients participating in any other clinical trails currently，or participated in other trails within 1 months.
5. Without a history of stomach or esophageal cancers, including stromal tumor，sarcoma，lymphoma and carcinoid.
6. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
7. Patients with poor compliance or considered to be poor compliance.References
Publications (11)
- BACKGROUNDMezhir JJ, Posner MC, Roggin KK. Prospective clinical trial of diagnostic peritoneal lavage to detect positive peritoneal cytology in patients with gastric cancer. J Surg Oncol. 2013 Jun;107(8):794-8. doi: 10.1002/jso.23328. Epub 2013 Mar 26. PMID 23532564
- BACKGROUNDTang B, Peng ZH, Yu PW, Yu G, Qian F, Zeng DZ, Zhao YL, Shi Y, Hao YX, Luo HX. Aberrant expression of Cx43 is associated with the peritoneal metastasis of gastric cancer and Cx43-mediated gap junction enhances gastric cancer cell diapedesis from peritoneal mesothelium. PLoS One. 2013 Sep 11;8(9):e74527. doi: 10.1371/journal.pone.0074527. eCollection 2013. PMID 24040271
- BACKGROUNDHamazoe R, Maeta M, Kaibara N. Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer. 1994 Apr 15;73(8):2048-52. doi: 10.1002/1097-0142(19940415)73:83.0.co;2-q. PMID 8156509
- BACKGROUNDXu DZ, Zhan YQ, Sun XW, Cao SM, Geng QR. Meta-analysis of intraperitoneal chemotherapy for gastric cancer. World J Gastroenterol. 2004 Sep 15;10(18):2727-30. doi: 10.3748/wjg.v10.i18.2727. PMID 15309728
- BACKGROUNDSautner T, Hofbauer F, Depisch D, Schiessel R, Jakesz R. Adjuvant intraperitoneal cisplatin chemotherapy does not improve long-term survival after surgery for advanced gastric cancer. J Clin Oncol. 1994 May;12(5):970-4. doi: 10.1200/JCO.1994.12.5.970. PMID 8164049
- BACKGROUNDRosen HR, Jatzko G, Repse S, Potrc S, Neudorfer H, Sandbichler P, Zacherl J, Rabl H, Holzberger P, Lisborg P, Czeijka M. Adjuvant intraperitoneal chemotherapy with carbon-adsorbed mitomycin in patients with gastric cancer: results of a randomized multicenter trial of the Austrian Working Group for Surgical Oncology. J Clin Oncol. 1998 Aug;16(8):2733-8. doi: 10.1200/JCO.1998.16.8.2733. PMID 9704725
- Coccolini F, Cotte E, Glehen O, Lotti M, Poiasina E, Catena F, Yonemura Y, Ansaloni L. Intraperitoneal chemotherapy in advanced gastric cancer. Meta-analysis of randomized trials. Eur J Surg Oncol. 2014 Jan;40(1):12-26. doi: 10.1016/j.ejso.2013.10.019. Epub 2013 Nov 5.