UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031780 |
|---|---|
| Receipt number | R000036279 |
| Scientific Title | Extensive Peritoneal Lavage after Curative Gastrectomy for Gastric Cancer: a Randomized Controlled Trial (EXPEL Study) |
| Date of disclosure of the study information | 2018/03/21 |
| Last modified on | 2020/03/25 09:34:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Extensive Peritoneal Lavage after Curative Gastrectomy for Gastric Cancer: a Randomized Controlled Trial (EXPEL Study)
Acronym
Extensive Peritoneal Lavage for Gastric Cancer (P3)
Scientific Title
Extensive Peritoneal Lavage after Curative Gastrectomy for Gastric Cancer: a Randomized Controlled Trial (EXPEL Study)
Scientific Title:Acronym
Extensive Peritoneal Lavage for Gastric Cancer (P3)
Region
| Japan | Asia(except Japan) |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Disease free survival
Peritoneal recurrence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Study arm: Extensive peritoneal lavage. The peritoneal cavity will be washed with 10 liters of normal saline (1 liter each cycle for 10 cycles).
Interventions/Control_2
Control arm: Standard treatment. The peritoneal cavity will be washed within 2 liters of normal saline.
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
| 21 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.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.
2.Patients planned for open or laparoscopic gastrectomy.
3.Patients undergoing gastrectomy with curative intent.
4.Lower age limit of research subjects 21 years old and upper age limit of 80 years old.
5.Ability to provide informed consent
6.Ability to come back for study visits throughout the 3 years duration after surgery
7.Patients are local residents
Key exclusion criteria
1.Patients who undergo a palliative gastrectomy.
2.Patients who undergo a gastrectomy as emergency.
3.Vulnerable persons under age of 21.
4.Patients receiving neoadjuvant therapy.
5.Patients presented with life-threatening bleeding from tumour
6.ASA score of 4 & 5
7.Patients with another primary cancer within last 5 years
8.Patients with gross peritoneal and liver metastasis at surgery.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jimmy So |
Organization
National University Hospital, Singapore
Division name
Department of Surgery
Zip code
Address
National University Hospital Singapore Pte Ltd, 5 Lower Kent Ridge Road, Singapore 119074
TEL
+65-6772-3191
sursbyj@nus.edu.sg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Prof. Jimmy So |
Organization
National University Hospital, Singapore
Division name
Department of Surgery
Zip code
Address
National University Hospital Singapore Pte Ltd, 5 Lower Kent Ridge Road, Singapore 119074
TEL
+65-6772-3191
Homepage URL
https://clinicaltrials.gov/ct2/show/study/NCT02140034?term=NCT%3A02140034&rank=1&view=record
sursbyj@nus.edu.sg
Sponsor or person
Institute
National University Hospital, Singapore
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
YES
Study ID_1
NCT:02140034
Org. issuing International ID_1
Clinical Trial.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター東病院（千葉県）、福島県立医科大学（福島県）、岐阜大学附属病院（岐阜県）、静岡県立静岡がんセンター（静岡県）、愛知県がんセンター（愛知県）、新潟県立新潟がんセンター（新潟県）、神奈川県立がんセンター（神奈川県）、国立シンガポール大学（シンガポール）、Tan Tock Seng病院（シンガポール）、Ajou大学（韓国）、Yonsei大学（韓国）、Peking大学(中国)、Seoul National大学（韓国）、Seoul National大学Bundang病院（韓国）、National cancer center（韓国）、国立マレーシア大学（マレーシア）、Queen mary病院（香港）、Southern medical大学Nanfang病院（中国）、the Chinese University of Hong Kong Prince of Wales病院(香港)、Seoul St. Mary's病院（韓国）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2018 | Year | 03 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
