UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006784 |
|---|---|
| Receipt number | R000008027 |
| Scientific Title | Laparoscopic distal pancreatectomy and partial resection for benign or low grade malignant neoplasms. |
| Date of disclosure of the study information | 2011/11/28 |
| Last modified on | 2011/11/28 16:24:08 |
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Basic information
Public title
Laparoscopic distal pancreatectomy and partial resection for benign or low grade malignant neoplasms.
Acronym
Laparoscopic distal pancreatectomy and partial resection for benign or low grade malignant neoplasms.
Scientific Title
Laparoscopic distal pancreatectomy and partial resection for benign or low grade malignant neoplasms.
Scientific Title:Acronym
Laparoscopic distal pancreatectomy and partial resection for benign or low grade malignant neoplasms.
Region
| Japan |
Condition
Condition
Benign or low grade pancreatic tumors which are possible to conduct laparoscopic resection
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the outcome and safety of laparoscopic distal pancreatectomy and partial resection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood loss, volume of transfusion, operation time, degree of postoperative pain, morbidity, mortality, postoperative hospital stay
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Laparoscopic surgery
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
Benign or low grade malignant pancreatic tumors which are possible to conduct laparoscopic resection.
Key exclusion criteria
Benign or low grade malignant pancreatic tumors which are impossible to conduct laparoscopic resection and malignant tumors.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Taniguchi |
Organization
Yokohama City University
Division name
Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University
Division name
Gastroenterological Surgery
Zip code
Address
TEL
045-787-2650
Homepage URL
Sponsor or person
Institute
Yokohama City University
Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 28 | 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
| 2011 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
Management information
Registered date
| 2011 | Year | 11 | Month | 28 | Day |
Last modified on
| 2011 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008027
| 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 |
