UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019480 |
|---|---|
| Receipt number | R000022425 |
| Scientific Title | Randomized controlled study of early replacement with factor XIII for fistula after pancreatic surgery (FIPS) |
| Date of disclosure of the study information | 2015/10/25 |
| Last modified on | 2020/02/18 10:19:47 |
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Basic information
Public title
Randomized controlled study of early replacement with factor XIII for fistula after pancreatic surgery (FIPS)
Acronym
RCT of early replacement with factor XIII for pancreatic fistula
Scientific Title
Randomized controlled study of early replacement with factor XIII for fistula after pancreatic surgery (FIPS)
Scientific Title:Acronym
RCT of early replacement with factor XIII for pancreatic fistula
Region
| Japan |
Condition
Condition
Fistula after pancreatic surgery
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether coagulation factor XIII promote the cure of fistula after pancreatic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The length of pancreatic fistula cure after the recovery of inflammation and alimination
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Early replacement with coagulation factor XIII
Interventions/Control_2
Replacement with coagulation factor XIII over 2 weeks after recovery of inflammation and alimentation
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) Patient with drain over 7 days for pancreatic fistula after pancreaticoduodenectomy or distal pancreatectomy
2) Coagulation factor XIII is 70% or less after postoperative day 7
3) CRP < 2mg/dl
4) Over 20 years old
5) Patients with written informed consent
Key exclusion criteria
1) Alb < 2.5g/dl
2) With other inflammation
3) Thrombotic disease
4) Hemolytic anemia or blood loss anemia
5) Compromised immune system or immunosuppressed
6) Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Saiura |
Organization
Cancer Institute Hospital
Division name
Department of Hepato-biliary-pancreatic surgery
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
akio.saiura@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Takeda |
Organization
Cancer Institute Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
Homepage URL
yoshinori.takeda@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
がん研究会有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00423-018-1736-4
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 11 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 25 | 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
| 2015 | Year | 10 | Month | 23 | Day |
Last modified on
| 2020 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022425
