UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036957 |
|---|---|
| Receipt number | R000042106 |
| Scientific Title | study for safety of robot-assisted laparoscopic spleen-preserving distal pancreatectomy using Da Vinci for pancreatic diseases |
| Date of disclosure of the study information | 2019/06/04 |
| Last modified on | 2019/06/04 15:01:25 |
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Basic information
Public title
study for safety of robot-assisted laparoscopic spleen-preserving distal pancreatectomy
Acronym
robot-assisted laparoscopic spleen-preserving distal pancreatectomy
Scientific Title
study for safety of robot-assisted laparoscopic spleen-preserving distal pancreatectomy using Da Vinci for pancreatic diseases
Scientific Title:Acronym
robot-assisted laparoscopic spleen-preserving distal pancreatectomy
Region
| Japan |
Condition
Condition
pancreatic neoplasm except for cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of robot-assisted laparoscopic spleen-sparing pancreatic caudal resection
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Robot-assisted surgery completion rate
Total adverse event rate
Key secondary outcomes
Operation time, intraoperative blood loss
Postoperative pancreatic fistula rate
Postoperative days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robot-assisted laparoscopic spleen-preserving distal pancreatectomy using the Da Vinci Surgical System
One surgical intervention, from start to finish
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
(1) Name of disease: Low-grade pancreatic tumor.
(2) Site: A lesion localized to the tail of the pancreatic body with preservable splenic vessels.
(3) Performance Status : 0-2
(4) The function of the tumor organ is maintained
Key exclusion criteria
(1) History of upper abdominal surgery
(2) Complication of malignant tumor
(3) Complication of active acute pancreatitis, chronic pancreatitis
(4) Emergent operation
(5) Pregnant cases: Pregnancy, lactation
(6) Cases that participation in research is difficult due to a combination of psychosis or psychiatric symptoms
(7) Cases judged by doctors as inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Ishida |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery
Zip code
989-8574
Address
1-1 Seiryocho, Aobaku, Sendai
TEL
022-717-7205
mishida@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masaharu |
| Middle name | |
| Last name | Ishida |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery
Zip code
989-8574
Address
1-1 Seiryocho, Aobaku, Sendai
TEL
022-717-7205
Homepage URL
mishida@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Tohoku University Graduate School of Medicine
Address
1-1 Seiryocho, Aobaku, Sendai
Tel
022-717-7205
mishida@surg.med.tohoku.ac.jp
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
| 2019 | Year | 06 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2019 | Year | 06 | Month | 04 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042106
