UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001967 |
|---|---|
| Receipt number | R000002402 |
| Scientific Title | A prospective randomized controlled trial comparing isolated Roux-en-Y reconstruction with Billroth-II-type reconstruction after pancreaticoduodenectomy |
| Date of disclosure of the study information | 2009/05/13 |
| Last modified on | 2016/07/19 22:33:35 |
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Basic information
Public title
A prospective randomized controlled trial comparing isolated Roux-en-Y reconstruction with Billroth-II-type reconstruction after pancreaticoduodenectomy
Acronym
Evaluation of isolated Roux-en-Y reconstruction after pancreaticoduodenectomy
Scientific Title
A prospective randomized controlled trial comparing isolated Roux-en-Y reconstruction with Billroth-II-type reconstruction after pancreaticoduodenectomy
Scientific Title:Acronym
Evaluation of isolated Roux-en-Y reconstruction after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
pancreatic cancer, biliary cancer, duodenal cancer, pancreatic tumor, biliary tumor,duodenal tumor
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 incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
pancratic fistula
Key secondary outcomes
the incidence of other postoperative complications, mortality, delayed ggastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reconstruction after pancreaticoduodenectomy with Billroth-II-type
Interventions/Control_2
Reconstruction after pancreaticoduodenectomy with isolated Roux-en-Y
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
Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital
Key exclusion criteria
1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaji Tani |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
matani@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaji Tani |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
Homepage URL
srg2@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
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
| 2009 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 13 | Day |
Last modified on
| 2016 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002402
