UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009059 |
|---|---|
| Receipt number | R000010635 |
| Scientific Title | A clinical study of robotic-assisted laparoscopic pancreatic surgery. |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2023/11/23 15:33:14 |
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Basic information
Public title
A clinical study of robotic-assisted laparoscopic pancreatic surgery.
Acronym
A clinical study of robotic-assisted laparoscopic pancreatic surgery.
Scientific Title
A clinical study of robotic-assisted laparoscopic pancreatic surgery.
Scientific Title:Acronym
A clinical study of robotic-assisted laparoscopic pancreatic surgery.
Region
| Japan |
Condition
Condition
Pancreato-biliary tumors, chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness and feasibility of robotic-assisted laparoscopic pancreatic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of adverse events
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robotic-assisted laparoscopin pancreatic 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
Patients with pancreato-biliary tumor or chronic pancreatitis.
Patients who wish to come into compliance with protocol.
Each patient voluntarily gave written informed consent before treatment.
Key exclusion criteria
Patients with active malignant disease.
Patients who is or may be pregnant.
Patients who is breast feeding at the time of treatment.
Patients who are not suitable for laparoscopic surgery.
Patients who are not considered for being eligible to this trial by investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirochika Toyama |
Organization
Kobe University
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuou-ku, Kobe, Japan
TEL
08-382-6302
toyama@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadahiro Goto |
Organization
Kobe University
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuou-ku, Kobe, Japan
TEL
08-382-6302
Homepage URL
tdhrgoto@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine
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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | 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
| 2012 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2012 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010635
