UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001712 |
|---|---|
| Receipt number | R000002046 |
| Scientific Title | Prospective Randomized Controlled Study of Gastric Emptying Assessed by 13C-Acetate Breath Test After Pylorus-Preserving Pancreaticoduodenectomy. Comparison between Antecolic and Vertical Retrocolic Duodenojejunostomy |
| Date of disclosure of the study information | 2009/02/17 |
| Last modified on | 2013/09/04 10:40:59 |
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Basic information
Public title
Prospective Randomized Controlled Study of Gastric Emptying Assessed by 13C-Acetate Breath Test After Pylorus-Preserving Pancreaticoduodenectomy. Comparison between Antecolic and Vertical Retrocolic Duodenojejunostomy
Acronym
Prospective Randomized Controlled Study of Gastric Emptying Assessed by 13C-Acetate Breath Test After Pylorus-Preserving Pancreaticoduodenectomy. Comparison between Antecolic and Vertical Retrocolic Duodenojejunostomy
Scientific Title
Prospective Randomized Controlled Study of Gastric Emptying Assessed by 13C-Acetate Breath Test After Pylorus-Preserving Pancreaticoduodenectomy. Comparison between Antecolic and Vertical Retrocolic Duodenojejunostomy
Scientific Title:Acronym
Prospective Randomized Controlled Study of Gastric Emptying Assessed by 13C-Acetate Breath Test After Pylorus-Preserving Pancreaticoduodenectomy. Comparison between Antecolic and Vertical Retrocolic Duodenojejunostomy
Region
| Japan |
Condition
Condition
Pylorus preserving pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether vertical retrocolic duodenojejunostomy is superior to antecolic duodenojejunostomy with respect to gastric emptying in a prospective, randomized, controlled study of patients undergoing pylorus-preserving pancreaticoduodenectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric emptying after Pylorus preserving pancreaticoduodenectomy
Key secondary outcomes
Postoperative morbidity rate, length of hospital stay and the number of days to take in an appropriate amount of solid food orally
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 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
Antecolic duodenojejunostomy in the pylorus preserving pancreaticoduodenectomy
Interventions/Control_2
Vertical retrocolic duodenojejunostomy in the pylorus preserving 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of pancreato-biliary malignant tumor undergoing pylorus preserving pancreaticojejunostomy
Key exclusion criteria
Not performed pylorus preserving pancreaticojejunostomy; inoperable case, pancreaticoduodenectomy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Chijiiwa |
Organization
Miyazaki University School of Medicine
Division name
Department of Surgical Oncology and Regulation of Organ Function
Zip code
Address
Kihara 5200, Kiyotake, Miyazaki, Japan
TEL
0985-85-2905
kazuochi@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Chijiiwa |
Organization
Miyazaki University School of Medicine
Division name
Department of Surgical Oncology and Regulation of Organ Function
Zip code
Address
Kihara 5200, Kiyotake, Miyazaki, Japan
TEL
0985-85-2905
Homepage URL
kazuochi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology and Regulation of Organ Function, Miyazaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Miyazaki University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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 | 02 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2005 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | 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 | 02 | Month | 16 | Day |
Last modified on
| 2013 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002046
