UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001590 |
|---|---|
| Receipt number | R000001909 |
| Scientific Title | Extensive Intraoperative Peritoneal Lavage (EIPL) as a Standard Prophylactic Strategy for Peritoneal Recurrence in Patients with Gastric Carcinoma |
| Date of disclosure of the study information | 2008/12/18 |
| Last modified on | 2010/05/11 18:35:44 |
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Basic information
Public title
Extensive Intraoperative Peritoneal Lavage (EIPL) as a Standard Prophylactic Strategy for Peritoneal Recurrence in Patients with Gastric Carcinoma
Acronym
Extensive Intraoperative Peritoneal Lavage (EIPL) as a Standard Prophylactic Strategy for Peritoneal Recurrence in Patients with Gastric Carcinoma
Scientific Title
Extensive Intraoperative Peritoneal Lavage (EIPL) as a Standard Prophylactic Strategy for Peritoneal Recurrence in Patients with Gastric Carcinoma
Scientific Title:Acronym
Extensive Intraoperative Peritoneal Lavage (EIPL) as a Standard Prophylactic Strategy for Peritoneal Recurrence in Patients with Gastric Carcinoma
Region
| Japan |
Condition
Condition
Patients with Gastric Carcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to evaluate the efficacy of extensive intraoperative peritoneal lavage followed by intraperitoneal chemotherapy (EIPL-IPC) on the survival of advanced gastric cancer patients with intraperitoneal free cancer cells as a prophylactic strategy for peritoneal metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
overall 5-year survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Surgery alone
Interventions/Control_2
Surgery + IPC
Interventions/Control_3
Surgery + IPC + EIPL
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Advanced gastric cancer patients having peritoneal free cancer cells without overt peritoneal metastasis
2) Histologically diagnosed as gastric cancer
3) Having no distant metastasis
4) No treatment before surgical operation
5) Patients with PS0 or PS1
6) Patients with well primary organ function
Key exclusion criteria
1) Active concomitant malignancy
2) Unstable angina, recent myocardial infarction, heart failure
3) Uncontorolled diabetes or hypertension
4) Liver cirrhosis
5) Interstitial pneumonitis and severe emphysema
4) Other severe complications
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Shimada |
Organization
Yatsushiro Social Insurance General Hospital
Division name
Surgery
Zip code
Address
2-26 Matsuejo, Yatsusiro, Kumamoto, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yatsushiro Social Insurance General Hospital
Division name
Surgery
Zip code
Address
TEL
Homepage URL
shimadas@yatsushiro-gh.jp
Sponsor or person
Institute
Yatsushiro Social Insurance General Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Science and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 12 | Month | 18 | 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
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
Completed
Date of protocol fixation
| 1994 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1995 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 18 | Day |
Last modified on
| 2010 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001909
