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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036191
Receipt No. R000041232
Scientific Title Multi-center Prospective Clinical Study for Efficacy and Safety of Laparoscopic Double-Flap Reconstruction on Anti-reflux Potential to the Esophagus after Surgery
Date of disclosure of the study information 2019/05/01
Last modified on 2019/03/13

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Basic information
Public title Multi-center Prospective Clinical Study for Efficacy and Safety of Laparoscopic Double-Flap Reconstruction on Anti-reflux Potential to the Esophagus after Surgery
Acronym lD-FLAP Study
Scientific Title Multi-center Prospective Clinical Study for Efficacy and Safety of Laparoscopic Double-Flap Reconstruction on Anti-reflux Potential to the Esophagus after Surgery
Scientific Title:Acronym lD-FLAP Study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of laparoscopic proximal gastrectomy with lymphadenectomy followed by double-flap reconstruction on anti-reflux potential to the esophagus for patients with early gastric cancer in the upper stomach
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of reflux esophagitis at 1 year after surgery
Key secondary outcomes Incidence of anastomosis-related complications such as leakage, stricture and bleeding

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Laparoscopic proximal gastrectomy with lymphadenectomy followed by double-flap reconstruction
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically diagnosed with gastric cancer.
2) Diagnosed with T1N0 according to Japanese Classification of Gastric Carcinoma (the 15th edition).
3) Tumor is located mainly in the upper stomach and proximal gastrectomy is considered oncologically appropriate.
4) Patients who can give written informed concent.
Key exclusion criteria 1) Pregnant women or women with a possible pregnancy.
2) Patients who are otherwise judged by the investigator as unsuitable for enrollment.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Toshiyoshi
Middle name
Last name Fujiwara
Organization Okayama University
Division name Gastroenterological Surgery
Zip code 700-8558
Address 2-5-1 Shikatacho, Kita-ku, Okayama
TEL 086-235-7257
Email toshi_f@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Shinji
Middle name
Last name Kuroda
Organization Okayama Unisversity
Division name Gastroenterological Surgery
Zip code 700-8558
Address 2-5-1 Shikatacho, Kita-ku, Okayama
TEL 086-235-7257
Homepage URL
Email shinkuro@okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization The Okayama Medical Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Ethics Committee
Address 2-5-1 Shikatacho, Kita-ku, Okayama
Tel 086-235-6938
Email mae6605@adm.okayama-u.ac.jp

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
2019 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2022 Year 03 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
2019 Year 03 Month 13 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041232

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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