UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059851 |
|---|---|
| Receipt number | R000068445 |
| Scientific Title | Phase II study to evaluate Extensive intraoperative peritoneal lavage (EIPL) for gastric cancer patients with positive cytology either by peritoneal lavage stamp method |
| Date of disclosure of the study information | 2025/11/22 |
| Last modified on | 2025/11/21 17:35:56 |
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Basic information
Public title
Phase II study to evaluate Extensive intraoperative peritoneal lavage (EIPL) for gastric cancer patients with
positive cytology either by peritoneal lavage stamp method
Acronym
Phase II study to evaluate EIPL for gastric cancer patients withpositive cytology
Scientific Title
Phase II study to evaluate Extensive intraoperative peritoneal lavage (EIPL) for gastric cancer patients with
positive cytology either by peritoneal lavage stamp method
Scientific Title:Acronym
Phase II study to evaluate EIPL for gastric cancer patients withpositive cytology
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of extensive lavage regarding recurrence free survival for patients with positive cytology either by extensive lavage or stamp method who during gastrectomy with D2 lymph node dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Recurrence free survival
Key secondary outcomes
Overall survival, Recurrence site, postoperative adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
extensive intra-peritoneal lavage for patients with CY or Stamp positve
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Masaichi |
| Middle name | |
| Last name | Ohira |
Organization
Osaka City University Hospital
Division name
Department of Gasgtroenterological Surgery
Zip code
545-8585
Address
1-4-3, Asahimachi, Abenoku, Osaka Citym Osaka Prefecture, Japan
TEL
81-6-6645-3835
y_miki@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Miki |
Organization
Osaka City University
Division name
Department of Gastroenterological Surgery
Zip code
545-8585
Address
1-4-3, Asahimachi, Abenoku, Osaka Citym Osaka Prefecture, Japan
TEL
81-6-6645-3835
Homepage URL
y_miki@omu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Hospital Institutional Review Board
Address
1-2-7, Asahimachi, Abenoku, Osaka Citym Osaka Prefecture, Japan
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
13
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068445
