UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038913 |
|---|---|
| Receipt number | R000044240 |
| Scientific Title | Blood MR-pro adrenomedullin in patients with pancreatic resection |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/06/20 11:20:53 |
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Basic information
Public title
Blood adrenomedullin in patients with pancreatic resection
Acronym
ADM in pancreatic disease
Scientific Title
Blood MR-pro adrenomedullin in patients with pancreatic resection
Scientific Title:Acronym
ADM in pancreatic disease
Region
| Japan |
Condition
Condition
Pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the role of adrenomedullin in pancreatic disease with pancreatic resection.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood MR-proADM concentration at three time points before, and 1, 3 months after pancreatic resection.
Key secondary outcomes
- Influence of MR-proADM on pancreatpgenic diabetes
- Postoperative complication
- Overall survival for pancreatic cancer
- Relapse-free survival for pancreatic cancer
- Changes in blood MR-proADM between before and after pancreatic resection
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
Planned for pancreatic resection
Key exclusion criteria
Decline participation in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Taumi |
| Middle name | |
| Last name | Fukumoto |
Organization
Kobe University Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783826302
fukumoto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachiyo |
| Middle name | |
| Last name | Shirakawa |
Organization
Kobe University Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783826302
Homepage URL
sachiyo@pearl.kobe-u.ac.jp
Sponsor or person
Institute
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine
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
Ethical committee of Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
0783826669
kansatsu@med.kobe-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
神戸大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 30 | 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
Follow-up analyses for cancer prognosis and diabetic prognosis in patients who underwent pancreatic resection.
Management information
Registered date
| 2019 | Year | 12 | Month | 17 | Day |
Last modified on
| 2020 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044240
