UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032684 |
|---|---|
| Receipt number | R000037263 |
| Scientific Title | Efficacy of Seprafilm for prevention of delayed gastric emptying after left-sided hepatectomy: clinical study |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2021/05/27 11:59:58 |
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Basic information
Public title
Efficacy of Seprafilm for prevention of delayed gastric emptying after left-sided hepatectomy: clinical study
Acronym
Prevention of DGE by Seprafilm after left-sided hepatectomy
Scientific Title
Efficacy of Seprafilm for prevention of delayed gastric emptying after left-sided hepatectomy: clinical study
Scientific Title:Acronym
Prevention of DGE by Seprafilm after left-sided hepatectomy
Region
| Japan |
Condition
Condition
Liver tumor to be indicated for left-sidied hepatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of Seprafilm for the prevention of the delayed gastric emptying after left-sided hepatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Frequency of delayed gastric emptying
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Satndard therapy group (no seprafilm)
Interventions/Control_2
Trial therapy group (Seprafilm)
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)Patients who have liver tumor to be indicated left-sided hepatectomy
2)Preoperative ECOG Performance Status is 0-1
3)Age over 20 years old at the day of surgery
4)Those whose written consent has been obtained
Key exclusion criteria
1)Patients who schedule to resect other organs (except gallbladder)
2)Patients who schedule to rebuild biliary duct
3)Patients who underwent gastrectomy
4)Patients with a history of severe hypersensitivity
5)Patients who have severe comorbidity
6)Patients who abuse drug
Patients who is mentally unstable
Patients who is difficult to communicate with a doctor
7)Patients during pregnancy or at risk of becoming pregnant
Others:Patients considered inappropriate by the study investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-E2,Suita yamadaoka, Osaka, 565-0871, Japan
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-E2,Suita yamadaoka, Osaka, 565-0871, Japan
TEL
06-6879-3251
Homepage URL
heguchi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery ,Osaka University, Japan
Institute
Department
Personal name
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
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
| 2018 | Year | 07 | 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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037263
