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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name