UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001957 |
|---|---|
| Receipt number | R000002383 |
| Scientific Title | A prospective randomized trial of Billroth-I versus Billroth-II reconstruction after pancreaticoduodenectomy with pancreaticogastrostomy reconstruction |
| Date of disclosure of the study information | 2009/05/11 |
| Last modified on | 2015/05/13 20:55:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective randomized trial of Billroth-I versus Billroth-II reconstruction after pancreaticoduodenectomy with pancreaticogastrostomy reconstruction
Acronym
A prospective randomized trial of Billroth-I versus Billroth-II reconstruction after pancreaticoduodenectomy
Scientific Title
A prospective randomized trial of Billroth-I versus Billroth-II reconstruction after pancreaticoduodenectomy with pancreaticogastrostomy reconstruction
Scientific Title:Acronym
A prospective randomized trial of Billroth-I versus Billroth-II reconstruction after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
pancreatic tumor, bile duct tumor, ampullary tumor, duodenal tumor
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospective randomized study for Billroth I versus Billroth II about postoperative complication and digestive ability after pancreaticoduodenectomy with pancreaticogastrostomy reconstruction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of DGE and postoperative hospital stay in the postoeprative early period.
Key secondary outcomes
Evaluation of nutriture, digestive ability, and pancreatic endocrine/exocrine secretory function in the postoperative late period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform Billroth I reconstruction after pancreaticoduodenectomy.
Interventions/Control_2
Perform Billroth II reconstruction 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
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases with pancreatic tumor, bile duct tumor, ampullary tumor, or duodenal tumor who received macroscopic curative resection by pancreticoduodenectomy.
Performance status 0 or 1.
Key exclusion criteria
Case who did not received curative resection for cancer.
Performance status 2 or 3.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kurahara |
Organization
Kagoshima University
Division name
Surgical Oncology and Digestive Surgery
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima
TEL
099-275-5361
h-krhr@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kurahara |
Organization
Kagoshima University
Division name
Surgical Oncology and Digestive Surgery
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima
TEL
099-275-5361
Homepage URL
h-krhr@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences Kagosima University
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
20-46
Org. issuing International ID_1
Kagoshima University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鹿児島大学病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 11 | 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
| 2008 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 11 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002383
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
