UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010864 |
|---|---|
| Receipt number | R000012719 |
| Scientific Title | Evaluation of safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2016/12/19 22:58:02 |
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Basic information
Public title
Evaluation of safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Acronym
Laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Scientific Title
Evaluation of safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Scientific Title:Acronym
Laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Region
| Japan |
Condition
Condition
Neuroendocrine tumor
mucinous cystic neoplasm
serous cystic neoplasm
intraductal papillary mucinous neoplasm
Solid Pseudopapillary neoplasm
, etc.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complication rate
Key secondary outcomes
Conversion rate
Rate of postoperative pancreatic fistula
R0 resection rate
Postoperative hospital stay
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
Laparoscopy-assisted pancreaticoduodenectomy
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)Benign and low-grade malignant tumor of the pancreatic head
2)ECOG Performance Status:0-1
3)BMI equal to or lower than 25
4)Major organ function is preserved and general anesthesia is possible
5)Signed informed consent
Key exclusion criteria
1)Patients diagnosed as pancreatic ductal carcinoma or suspected
2)Synchronous malignancyes
3)Emergency surgery
4)Acute or chronic pancreatitis
5)Acute cholangitis
6)Women during pregnancy
7)Patients possible to perform enucleation or partial resection
8)Patients judged as inadequate by investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Morikawa |
Organization
Tohoku University Hospital
Division name
Division of Hepato-Biliary Pancreatic surgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
t_morikawa@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Morikawa |
Organization
Tohoku University Hospital
Division name
Division of Hepato-Biliary Pancreatic surgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
t_morikawa@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Hepato-Biliary Pancreatic surgery, Tohoku University (Graduate School of Medicine)
Institute
Department
Personal name
Funding Source
Organization
Division of Hepato-Biliary Pancreatic surgery, Tohoku University (Graduate School of Medicine)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of gastrointestinal and pediatric surgery, Tokyo medical university
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
| 2013 | Year | 07 | Month | 01 | 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
| 2013 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
| 2013 | Year | 06 | Month | 04 | Day |
Last modified on
| 2016 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012719
