UMIN-CTR Clinical Trial

Basic information
Public title	The analysis of the association between the delayed gastric emptying and the anatomical position of stomach/jejunum following pancreatoduodenectomy.
Acronym	Delayed gastric emptying and the anatomical position of stomach/jejunum.
Scientific Title	The analysis of the association between the delayed gastric emptying and the anatomical position of stomach/jejunum following pancreatoduodenectomy.
Scientific Title:Acronym	Delayed gastric emptying and the anatomical position of stomach/jejunum.
Region	Japan

Condition
Condition	Patients who undergo pancreatoduodenectomy
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the association between the anatomical position of stomach/jejunum and the incidence of delayed gastric emptying.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To analyze the association between the incidence of delayed gastric emptying and the relative deviation of gastrojejunostomy to esophago-gastric junction (both laterally and ventriculary) using correlation analysis.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Abdominal CT scan at 1 week after surgery. Upper gastrointestinal imaging at 1 week after surgery.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who undergo pancreatoduodenectomy. 2) Patients who agreed to participate this study with his/her own decision.
Key exclusion criteria	1) Patients who refused to participate this study. 2) Patients who are not eligible to this study (by the decision of examiners). 3) Patients after gastrectomy.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Nagino
Organization	Nagoya University Graduate School of Medicine
Division name	Division of Surgical Oncology, Department of Surgery,
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Aichi, Japan 466-8550
TEL	+81-52-744-2222
Email	nagino@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Yokoyama
Organization	Nagoya University Hospital
Division name	Surgery 1
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Aichi, Japan
TEL	+81-52-744-2222
Homepage URL
Email	yyoko@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Nagoya University Hospital
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	Nagoya Unviersity Hospital
Address	65 Tsurumai-cho, Showa-ku, Aichi, Japan
Tel	+81527441901
Email	ethics@med.nagoya-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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 31 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	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Date of IRB	2017 Year 01 Month 31 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 02 Month 03 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019084