UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016433
Receipt number R000019084
Scientific Title The analysis of the association between the delayed gastric emptying and the anatomical position of stomach/jejunum following pancreatoduodenectomy.
Date of disclosure of the study information 2018/03/31
Last modified on 2019/08/08 09:15:21

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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 or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name