UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012337 |
|---|---|
| Receipt number | R000014425 |
| Scientific Title | A prospective comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy on postoperative delayed gastric emptying. |
| Date of disclosure of the study information | 2013/11/19 |
| Last modified on | 2013/11/18 21:08:36 |
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Basic information
Public title
A prospective comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy on postoperative delayed gastric emptying.
Acronym
A prospective comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy
Scientific Title
A prospective comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy on postoperative delayed gastric emptying.
Scientific Title:Acronym
A prospective comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy
Region
| Japan |
Condition
Condition
pancreato-biliary desease of the pancreas head
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence rates of DGE between PPPD and SSPPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence rates of DGE
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PPPD
Interventions/Control_2
SSPPD
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases of pancreato-biliary disease who need pancratoduodenectomy
Key exclusion criteria
invasive ductal adenocarcinoma of the pancreas
tumor infiltration into the stomach
metastasis into lymph nodes of the peripylorus
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yonson Ku |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery
Zip code
Address
7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL
078-382-6302
yonson@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ippei Matsumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery
Zip code
Address
7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL
078-382-6302
Homepage URL
imatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 11 | Month | 19 | 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
| 2002 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 18 | Day |
Last modified on
| 2013 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014425
