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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029732
Receipt No. R000033633
Scientific Title Epidemic Research of Treatment for Gastric Outlet Stenosis due to Gastric Cancer in Japan
Date of disclosure of the study information 2017/10/29
Last modified on 2019/04/28

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Basic information
Public title Epidemic Research of Treatment for Gastric Outlet Stenosis due to Gastric Cancer in Japan
Acronym ERGO-J study
Scientific Title Epidemic Research of Treatment for Gastric Outlet Stenosis due to Gastric Cancer in Japan
Scientific Title:Acronym ERGO-J study
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the actual status of treatment options for gastric outlet stenosis due to gastric cancer in Japan and to analyze their efficacy, safety and prognostic factors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative time for which at least liquid can be taken.
Key secondary outcomes 1. short-term outcome
Clinical success of treatment
Postoperative complications
In-hospital death
Postoperative length of stay
Technical success of stent insertion
Removal of stent
2. Long-term outcome
Overall survival
Induction of chemotherapy
Transition to resection
Obstruction of stent

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients who underwent endoscopic stenting or gastroenterostomy for stenosis of gastric pylorus or duodenum due to gastric cancer between January 2015 and December 2015.
Key exclusion criteria Non-epithelial tumors
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Yoshida
Organization Gifu University Graduate School of Medicine
Division name Department of Surgical Oncology Oncology
Zip code 5011194
Address 1-1 Yanagido, Gifu, 501-1194 Japan
TEL 81-58-230-6235
Email kyoshida@gifu-u.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Haga
Organization Japan Community Healthcare Organization Amakusa Central General Hospital
Division name Surgery
Zip code 8630033
Address 101 Higashi-machi, Amakusa-shi, Kumamoto-ken 863-0033, Japan
TEL 81-969-22-0011
Homepage URL
Email epass2006@outlook.com

Sponsor
Institute Japan Gastric Cancer Association
Institute
Department

Funding Source
Organization Japan Gastric Cancer Association
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 Japan Community Healthcare Organization Amakusa Central General Hospital
Address 101 Higashi-machi, Amakusa-shi, Kumamoto-ken 863-0033, Japan
Tel 81-969-22-0011
Email epass2006@outlook.com

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
2017 Year 10 Month 29 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
2017 Year 08 Month 05 Day
Date of IRB
2015 Year 12 Month 04 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2018 Year 09 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Variables to be collected

1-1. Preoperative variables
1) Demographic data: age, gender, height, weight
2) Preoperative tumor evaluation: depth of invasion, lymph node metastasis, distant metastasis (organs), macroscopic type, location of the tumor
3) Preoperative physical status: Duration of impaired food intake, Food intake (Gastric Outlet Obstruction Score: GOOS), Performance status, biliary stenting, serum C-reactive protein level, serum albumin level, serum sodium level, lymphocyte count, neutrophil count, hemoglobin level, tumor marker levels (CEA, CA19-9), severe heart disease, severe pulmonary disease, diabetes mellitus, American Society Association physical status for patients undergoing gastroenterostomy

1-2. Operative variables
Surgical procedures.
For stenting, maker, product, covering.
For gastroenterostomy, blood loss during operation, operation time, surgical approach (laparotomy or laparoscopic), anastomosis method (hand-sewn or stapling), anastomotic site, Braun anastomosis, partitioning

Management information
Registered date
2017 Year 10 Month 26 Day
Last modified on
2019 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033633

Research Plan
Registered date File name
2018/01/24 ERGO-J1.5.1.pdf

Research case data specifications
Registered date File name
2018/01/24 datafile1.xlsx

Research case data
Registered date File name
2018/01/24 datafile2.xlsx


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