UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016866 |
|---|---|
| Receipt number | R000019574 |
| Scientific Title | A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy |
| Date of disclosure of the study information | 2015/03/22 |
| Last modified on | 2022/01/31 12:35:59 |
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Basic information
Public title
A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy
Acronym
A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy
Scientific Title
A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy
Scientific Title:Acronym
A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Periampullary diseases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To apply the new criteria for drain removal after pancreaticoduodenectomy in order to decrease the rate of pancreatic fistula and to decrease the rate of interventional drainage or relaparotomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of pancreatic fistula (Grade B or C)
Key secondary outcomes
BMI, comorbidity, preoperative steroids, operation time, intraoperative blood loss, years of experience of surgeons, pancreatic parencyma, rate of pancreatic fistula(Grade A), rate of bleeding after surgery, rate of intraperitoneal abscess, rate of interventional drainage, rate of relaparotomy, rate of DGE, postoperative pancreatitis, postoperative cholangitis, SSI, rate of morbidity, length of drain insertion, hospital stay, mortality, rate of readmission
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
New criteria for drain removal
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients received pancreaticoduodenectomy for periampullary diseases
Key exclusion criteria
Patients with severe comorbidity
Patients with dysfunction of vital organs
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Taniguchi |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city
TEL
045-787-2650
t1006koichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Taniguchi |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city
TEL
045-787-2650
Homepage URL
t1006koichi@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
| 2015 | Year | 03 | Month | 22 | 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
| 2012 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019574
