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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031780
Receipt No. 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 2018/03/18

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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
Email 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
Email sursbyj@nus.edu.sg

Sponsor
Institute National University Hospital, Singapore
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2014 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 07 Day
Last follow-up date
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
2018 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.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


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