UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036191 |
|---|---|
| Receipt number | 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 | 2023/03/16 09:33:02 |
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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
40
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
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
shinkuro@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041232
