UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005827 |
|---|---|
| Receipt number | R000006833 |
| Scientific Title | Comparison between antecolic and retrocolic gastrointestinal reconstruction in delayed gastric emptying after pancreaticoduodenectomy: A prospective randomized controlled multicenter trial. |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2021/06/30 01:12:43 |
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Basic information
Public title
Comparison between antecolic and retrocolic gastrointestinal reconstruction in delayed gastric emptying after pancreaticoduodenectomy: A prospective randomized controlled multicenter trial.
Acronym
A prospective randomized controlled multicenter trial of delayed gastric emptying after pancreaticoduodenectomy evaluating by gastrointestinal reconstruction
Scientific Title
Comparison between antecolic and retrocolic gastrointestinal reconstruction in delayed gastric emptying after pancreaticoduodenectomy: A prospective randomized controlled multicenter trial.
Scientific Title:Acronym
A prospective randomized controlled multicenter trial of delayed gastric emptying after pancreaticoduodenectomy evaluating by gastrointestinal reconstruction
Region
| Japan |
Condition
Condition
Periampullary tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of delayed gastric emptying defined by ISGPS
Key secondary outcomes
Incidence of other postoperative morbidity.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Retrocolic gastro- or duodeno-jejunostomy in the pancreaticoduodenectomy
Interventions/Control_2
Antecolic gastro- or duodeno-jejunostomy in the pancreaticoduodenectomy
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy
Key exclusion criteria
1)Patients who have the history of gastrectomy
2)Patients who have severe cardiorespiratory dysfunction
3)Patients who have liver cirrhosis or are receiving dialysis
4)Patients who were diagnosed inadequacy for this study by a physician
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yonson |
| Middle name | |
| Last name | Ku |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery
Zip code
6500017
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 | Hirochika |
| Middle name | |
| Last name | Toyama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery
Zip code
6500017
Address
7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL
078-382-6302
Homepage URL
toyama@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
none
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
kobe university
Address
kusunoki 7+5+2, Chuo-ku, Kobe, Japan
Tel
0783826302
tymhr@me.com
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
| 2011 | Year | 09 | Month | 01 | 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
| 2011 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006833
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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