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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011454
Receipt No. R000013410
Scientific Title Prospective randomized phase 2 trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy
Date of disclosure of the study information 2013/08/11
Last modified on 2018/02/13

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Basic information
Public title Prospective randomized phase 2 trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy
Acronym Prospective randomized phase 2 trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy
Scientific Title Prospective randomized phase 2 trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy
Scientific Title:Acronym Prospective randomized phase 2 trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy
Region
Japan

Condition
Condition Patients who need pancreaticoduodenectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the safety and efficacy including the incidence of delayed gastric emptying between pancreatogastrostomy or pancreatojejunostomy after pancreaticooduodenectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of delayed gastric emptying evaluated by ISGPS criteria
Key secondary outcomes

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 Pancreaticogastrostomy
Interventions/Control_2 Pancreaticojejunostomy
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 (1) Patients who need pancreaticooduodenectomy
(2) ECOG performance status of 0 or 1
(3) Age of 20 and more
(4) Patients without any distant metastases
(5) Adequate hematologic, hepatic, renal and respiratory function
(6) Written informed consent
Key exclusion criteria (1) Severe liver cirrhosis or severe active hepatitis
(2) Severe pulmonary disorders
(3) Severe renal disorders
(4) Active double cancer except carcinoma in situ or intramucosal cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 2 years)
(5) Hypersensitivity to eggs
(6) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Osaka University
Division name Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Email heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Osaka University
Division name Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email heguchi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka
Institute
Department

Funding Source
Organization None (Self-funding)
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 08 Month 11 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 No longer recruiting
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 11 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013410

Research Plan
Registered date File name
2014/12/24 CSGO-HBP-007_膵胃vs膵腸_プロトコル.doc

Research case data specifications
Registered date File name
2014/12/24 CSGO-HBP-007_膵胃vs膵腸_CRF.doc

Research case data
Registered date File name


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