UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026815 |
|---|---|
| Receipt number | R000030784 |
| Scientific Title | Postoperative visceral tissue edema assessed by computed tomography is a predictor of severe complications after pancreatoduodenectomy |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/04/02 19:37:40 |
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Basic information
Public title
Postoperative visceral tissue edema assessed by computed tomography is a predictor of severe complications after pancreatoduodenectomy
Acronym
Postoperative visceral tissue edema assessed by computed tomography after pancreatoduodenectomy
Scientific Title
Postoperative visceral tissue edema assessed by computed tomography is a predictor of severe complications after pancreatoduodenectomy
Scientific Title:Acronym
Postoperative visceral tissue edema assessed by computed tomography after pancreatoduodenectomy
Region
| Japan |
Condition
Condition
Disease undergping pancreatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether visceral tissue edema due to fluid overload assessed by CT affects postoperative severe complication after pancreatoduodenectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative severe complications after pancreatoduodenectomy (Clavien-Dindo classification of more than grade III) compared between developpement or non-developpment postoperative tissue edema
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
restricted perioperative fluid administration
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing pancreatoduodenectomy between June 2010 and December 2015 at the Wakayama Medical University Hospital
Key exclusion criteria
1) Patients with combined other organs
2) patients rejected to participate in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department od Surgery
Zip code
Address
Kimiidera 811-1, Wakayama, Japan
TEL
0734410613
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Shimizu |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department od Surgery
Zip code
Address
Kimiidera 811-1, Wakayama, Japan
TEL
0734410613
Homepage URL
atsus28@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department od Surgery, Wakayama Medical University, School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Severe complication (Clavien-Dindo more than grade III) rate was significantly higher in Liberal fluid management(LFM) group than Goal-directed fluid management(GDFT) group (37% vs. 17%, P = 0.001).
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
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030784
