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
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
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
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
