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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005827
Receipt No. R000006833
Scientific Title Comparison between antecolic and retrocolic gastrointestinal reconstruction in delayed gastric emptying after pancreaticoduodenectomy: A prospective randomized controlled multicenter trial.
Date of disclosure of the study information 2011/09/01
Last modified on 2021/06/30

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Basic information
Public title Comparison between antecolic and retrocolic gastrointestinal reconstruction in delayed gastric emptying after pancreaticoduodenectomy: A prospective randomized controlled multicenter trial.
Acronym A prospective randomized controlled multicenter trial of delayed gastric emptying after pancreaticoduodenectomy evaluating by gastrointestinal reconstruction
Scientific Title Comparison between antecolic and retrocolic gastrointestinal reconstruction in delayed gastric emptying after pancreaticoduodenectomy: A prospective randomized controlled multicenter trial.
Scientific Title:Acronym A prospective randomized controlled multicenter trial of delayed gastric emptying after pancreaticoduodenectomy evaluating by gastrointestinal reconstruction
Region
Japan

Condition
Condition Periampullary tumor
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of delayed gastric emptying defined by ISGPS
Key secondary outcomes Incidence of other postoperative morbidity.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Retrocolic gastro- or duodeno-jejunostomy in the pancreaticoduodenectomy
Interventions/Control_2 Antecolic gastro- or duodeno-jejunostomy in the 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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy
Key exclusion criteria 1)Patients who have the history of gastrectomy
2)Patients who have severe cardiorespiratory dysfunction
3)Patients who have liver cirrhosis or are receiving dialysis
4)Patients who were diagnosed inadequacy for this study by a physician
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Yonson
Middle name
Last name Ku
Organization Kobe University Graduate School of Medicine
Division name Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery
Zip code 6500017
Address 7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL 078-382-6302
Email yonson@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Hirochika
Middle name
Last name Toyama
Organization Kobe University Graduate School of Medicine
Division name Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery
Zip code 6500017
Address 7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL 078-382-6302
Homepage URL
Email toyama@med.kobe-u.ac.jp

Sponsor
Institute Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery,
Kobe University Graduate School of Medicine
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 kobe university
Address kusunoki 7+5+2, Chuo-ku, Kobe, Japan
Tel 0783826302
Email tymhr@me.com

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
2011 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2011 Year 06 Month 22 Day
Date of IRB
2011 Year 06 Month 22 Day
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 04 Month 01 Day
Date analysis concluded
2017 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 22 Day
Last modified on
2021 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006833

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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