UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011454 |
|---|---|
| Receipt number | 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 | 2020/02/15 11:36:21 |
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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 | Hidetoshi |
| Middle name | |
| Last name | Eguchi |
Organization
Osaka University
Division name
Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Eguchi |
Organization
Osaka University
Division name
Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
Homepage URL
heguchi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka
Institute
Department
Personal name
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
Osaka University Hospital Academic Clinical Research Center
Address
2-15 Yamadaoka Suita, Osaka Japan
Tel
06-6879-5685
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2013 | Year | 04 | Month | 01 | Day |
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
| 2020 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.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 |
