UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020813 |
|---|---|
| Receipt number | R000023859 |
| Scientific Title | Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy. |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2016/02/01 09:44:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Acronym
Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Scientific Title
Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Scientific Title:Acronym
Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Region
| Japan |
Condition
Condition
Hepato-biliary-pancreatic surgery
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate performance of pancreatico-jejunostomy and choledocho-jejunostomy, and to explore improvements.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of Pancreatic fistula
Incidence of Biliary fistula
Key secondary outcomes
Complications (incidence, severity, type)
30-day mortality
90-day mortality
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)patients who receive pancreatico-jejunostomy and/or choledocho-jejunostomy.
(2)patients over 20 years old
Key exclusion criteria
(1)patients without pancreatico-jejunostomy nor choledocho-jejunostomy.
(2)patients under 19 years old
(3)patients we judge to be inappropriate
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuyuhiko Motoi |
Organization
Tohoku University, Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7205
kein_h11@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Nakagawa |
Organization
Tohoku University, Graduate School of Medicine
Division name
Hepato-biliary-pancreatic surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7205
Homepage URL
kein_h11@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Surgery, Tohoku University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Tohoku University, Graduate School of Medicine
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
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
| 2016 | Year | 01 | Month | 31 | 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
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who are perfomed pancreatico-jejunostomy and/or choledocho-jejunostomy at Hepato-biliary-pancreatic surgery will be enrolled in this study.
Prospectively we record the medical record and inspection numerical values. Each annual, we analize to examine the risk factors for complications.
Management information
Registered date
| 2016 | Year | 01 | Month | 31 | Day |
Last modified on
| 2016 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023859
