UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048413 |
|---|---|
| Receipt number | R000055179 |
| Scientific Title | A prospective observational study of the onset of pancreaticojejunostomy stenosis and endoscopic treatment after pancreaticoduodenectomy |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2022/07/20 12:25:02 |
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Basic information
Public title
A prospective observational study of the onset of pancreaticojejunostomy stenosis and endoscopic treatment after pancreaticoduodenectomy
Acronym
A prospective observational study of the onset of pancreaticojejunostomy stenosis and endoscopic treatment after pancreaticoduodenectomy
Scientific Title
A prospective observational study of the onset of pancreaticojejunostomy stenosis and endoscopic treatment after pancreaticoduodenectomy
Scientific Title:Acronym
A prospective observational study of pancreaticojejunostomy stenosis and endoscopic treatment after PD
Region
| Japan |
Condition
Condition
Cases of pancreatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surveillance of clinical course of pancreaticojejunostomy stenosis after pancreaticoduodenectomy
Basic objectives2
Others
Basic objectives -Others
Clinical outcomes of endoscopic treatment for pancreaticojejunostomy stenosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and time to onset of pancreaticojejunostomy stenosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of pancreatoduodenectomy
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center Hospital
Division name
Gastroenterology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
0527626111
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Okuno |
Organization
Aichi Cancer Center Hospital
Division name
Gastroenterology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
0527626111
Homepage URL
nokuno@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
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
Aichi Cancer Center Hospital
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
Tel
0527626111
irb-jimu@aichi-cc.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20210146
Org. issuing International ID_1
Aichi Cancer Center Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2033 | Year | 01 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registered cases will be followed up for 5 years after surgery. Add necessary information to the CRF (Case Report Form) every year after registration.
Outcome surveys should be followed up as much as possible, and telephone surveys of patients and their families are also acceptable.
Management information
Registered date
| 2022 | Year | 07 | Month | 20 | Day |
Last modified on
| 2022 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055179
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
