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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001712
Receipt No. 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

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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
Email 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
Email kazuochi@med.miyazaki-u.ac.jp

Sponsor
Institute Department of Surgical Oncology and Regulation of Organ Function, Miyazaki University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002046

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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