UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative visceral tissue edema assessed by computed tomography is a predictor of severe complications after pancreatoduodenectomy
Title of the study (Brief title)	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	Hiroki Yamaue
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department od Surgery
Address	Kimiidera 811-1, Wakayama, Japan
TEL	0734410613
Email	yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person	Atsushi Shimizu
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department od Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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).
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/icdr_e/ctr_view.cgi?recptno=R000030784