UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033405 |
|---|---|
| Receipt number | R000038079 |
| Scientific Title | Short and Long - Term Outcomes of Choledochojejunostomy during Pancreaticoduodenectomy and Total Pancreatectomy: Interrupted Suture versus Continuous Suture. |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2018/07/16 17:38:36 |
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Basic information
Public title
Short and Long - Term Outcomes of Choledochojejunostomy during Pancreaticoduodenectomy and Total Pancreatectomy: Interrupted Suture versus Continuous Suture.
Acronym
Short and Long - Term Outcomes of Choledochojejunostomy: Interrupted Suture versus Continuous Suture.
Scientific Title
Short and Long - Term Outcomes of Choledochojejunostomy during Pancreaticoduodenectomy and Total Pancreatectomy: Interrupted Suture versus Continuous Suture.
Scientific Title:Acronym
Short and Long - Term Outcomes of Choledochojejunostomy: Interrupted Suture versus Continuous Suture.
Region
| Japan |
Condition
Condition
The patients who underwent pancreaticoduodenectomy or total pancreatectomy at Osaka International Cancer Institute.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the optimal method for choledochojejunostomy by comparing interrupted sutures and continuous sutures. Retrospective analyses using prospectively maintained clinical data base.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
short- and long- term complications related to choledochojejunostomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-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
Choledochojejunostomy performed by interrupted sutures.
Interventions/Control_2
Choledochojejunostomy performed by continuous sutures
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who undewent pancreaticoduodenectomy or total pancreatectomy in Osaka International Cancer Institute.
Key exclusion criteria
The patients who required extensive resection of the bile duct are not eligible for this analysis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Osaka International Cancer Institute
Division name
Department of Surgery
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, JAPAN
TEL
06-6945-1181
takahasi-hi@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Osaka International Cancer Institute
Division name
Department of Surgery
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, JAPAN
TEL
06-6945-1181
Homepage URL
takahasi-hi@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
The Osaka Foundation for The Prevention of Cancer and Life-style related Diseases
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2018 | Year | 07 | Month | 18 | 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
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | 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
| 2018 | Year | 07 | Month | 16 | Day |
Last modified on
| 2018 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038079
