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Phase II study to evaluate Extensive intraoperative peritoneal lavage (EIPL) for gastric cancer patients with positive cytology either by peritoneal lavage stamp method

Phase II study to evaluate Extensive intraoperative peritoneal lavage (EIPL) for gastric cancer patients with positive cytology either by peritoneal lavage stamp method - Phase II study to evaluate EIPL for gastric cancer patients withpositive cytology

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059851
Enrollment
65
Registered
2025-11-22
Start date
2017-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

extensive intra-peritoneal lavage for patients with CY or Stamp positve

Sponsors

Osaka City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically diagnosed with gastric cancer (pap, tub1, tub2, por1, por2, sig, muc, or a special type) based on endoscopic biopsy from the primary gastric lesion. Positive peritoneal lavage cytology or gastric wall imprint cytology, but no evidence of distant metastasis; eligible for R0/1 resection via gastrectomy with D2 lymph node dissection (including total or distal gastrectomy, and laparoscopic surgery). General anesthesia combined with epidural anesthesia will be used. Esophageal invasion is within 3 cm and no thoracotomy has been performed. Aged between 20 and 80 years. Performance Status (ECOG) of 0 or 1. No prior history of chemotherapy (including endocrine therapy) or radiotherapy, including for other malignancies. Meets all of the following laboratory criteria (based on the most recent preoperative test results within 56 days prior to enrollment; tests conducted on the same weekday up to 8 weeks before enrollment are acceptable): Data regarding WBC, Plt, AST, ALT, T-Bil, and Cre Written informed consent for participation in the study has been obtained from the patient.

Exclusion criteria

Exclusion criteria: Women who are pregnant or breastfeeding, or who may be pregnant. Individuals with psychiatric disorders or symptoms deemed unable to participate in the study. Individuals receiving continuous systemic administration of steroids (oral or intravenous). Individuals with a history of myocardial infarction within the past six months or with unstable angina. Individuals with uncontrolled hypertension. Individuals undergoing insulin therapy or with uncontrolled diabetes. Individuals with respiratory diseases requiring continuous oxygen therapy.

Design outcomes

Primary

MeasureTime frame
Recurrence free survival

Secondary

MeasureTime frame
Overall survival, Recurrence site, postoperative adverse events

Countries

Japan

Contacts

Public ContactYuichiro Miki

Osaka City University Department of Gastroenterological Surgery

y_miki@omu.ac.jp81-6-6645-3835

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026