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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001967
Receipt No. 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

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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
Email 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
Email srg2@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002402

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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