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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001957
Receipt No. 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

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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
Email 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
Email h-krhr@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences Kagosima University
Institute
Department

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
Email

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
URL(English) https://upload.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


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