UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036279