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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026815
Receipt No. 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

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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
Email 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
Email atsus28@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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