UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004757 |
|---|---|
| Receipt number | R000005658 |
| Scientific Title | A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy. |
| Date of disclosure of the study information | 2010/12/25 |
| Last modified on | 2024/07/01 16:33:57 |
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Basic information
Public title
A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.
Acronym
A usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.
Scientific Title
A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.
Scientific Title:Acronym
A usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.
Region
| Japan |
Condition
Condition
All disease to be indicated for the pancreatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the usefulness of the Braun anastomosis in the reconstruction after pancreaticoduodenectomy. A prospective randomized controlled trial is conducted to compare the incidence of complications with or without Braun anastomosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An adverse event until a discharge
Key secondary outcomes
A late adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reconstruction with Braun anastomosis after pancreaticoduodenectomy
Interventions/Control_2
Reconstruction without Braun anastomosis after 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A case performed pancreaticoduodenectomy at Dept. of surgery, Nagasaki Univ. hospital
Key exclusion criteria
1:a case not reconstructed by child method.
2:a case with combined resection of other organs
3:a case with severe complications.
4:a case judged to be inappropriate for the participation of the study by the attending surgeon
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ono Shinichiro |
Organization
Nagasaki University
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7316
shinichi0320_com@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ono Shinichiro |
Organization
Nagasaki University
Division name
Department of Surgery
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7316
Homepage URL
shinichi0320_com@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 12 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005658
