UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013282 |
|---|---|
| Receipt number | R000015488 |
| Scientific Title | Laparoscopy-assisted (pylorus preserved) pancreatoduodenectomy for reduction of surgical invasiveness |
| Date of disclosure of the study information | 2014/02/26 |
| Last modified on | 2019/03/12 13:29:26 |
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Basic information
Public title
Laparoscopy-assisted (pylorus preserved) pancreatoduodenectomy for reduction of surgical invasiveness
Acronym
Laparoscopy-assisted pancreatoduodenectomy
Scientific Title
Laparoscopy-assisted (pylorus preserved) pancreatoduodenectomy for reduction of surgical invasiveness
Scientific Title:Acronym
Laparoscopy-assisted pancreatoduodenectomy
Region
| Japan |
Condition
Condition
The patient who receives pancreatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reducing of surgical invasiveness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction
Evaluation of the patient satisfaction by a patient questionnaire
Key secondary outcomes
Incidence rate of postoperative complications
Postoperative hospitalization days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with periampullary lesions who will be treated until 1/31/2017
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 20years old over(At the time of hospitalization)
2.Patients with periampullary lesions who will be treated.
3.Patients who have been informed and have understood the full explanation of this study, and have agreed and given prior written consent.
Key exclusion criteria
1.Less than 20 years old
2.The cancer patient who accepts lymph node metastases by diagnostic imaging in preoperation
3.The patient whom it is judged to need blood vessel merger excision by video diagnosis in preoperation
4.The patient who is judged to be inappropriate by the examination medical attendant
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Eguchi |
Organization
Nagasaki University Hospital
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto,Nagasaki,JAPAN
TEL
095-819-7316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Amane Kitasato |
Organization
Nagasaki University Hospital
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto,Nagasaki,JAPAN
TEL
095-819-7316
Homepage URL
kitasato@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2014 | Year | 02 | Month | 26 | 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
| 2014 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 01 | 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
| 2014 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015488
| 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 |
