UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006092 |
|---|---|
| Receipt number | R000007209 |
| Scientific Title | Using the da Vinci surgical system S, consider the usefulness and safety of colorectal liver resection chest robotic-assisted laparoscopic esophagogastric |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2011/08/01 15:12:10 |
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Basic information
Public title
Using the da Vinci surgical system S, consider the usefulness and safety of colorectal liver resection chest robotic-assisted laparoscopic esophagogastric
Acronym
Examination of usefulness and safety of the da Vinci S Surgical
Scientific Title
Using the da Vinci surgical system S, consider the usefulness and safety of colorectal liver resection chest robotic-assisted laparoscopic esophagogastric
Scientific Title:Acronym
Examination of usefulness and safety of the da Vinci S Surgical
Region
| Japan |
Condition
Condition
Esophageal cancer, stomach cancer, colon cancer, liver cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Introducing the equipment into the University of Tokushima University Hospital offers this, consider the safety and efficacy of liver resection robot-assisted laparoscopic colon esophageal cancer esophageal cancer gastric cancer hepatic colorectal cancer, this after surgery in 40 patients in the study, to apply for advanced medical care for the ministry.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgery, postoperative complications, postoperative recovery time, postoperative pain, consider the histopathological findings of colorectal liver resected esophageal, safety and usefulness of this as a short-term results of surgery be considered.
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
10 cases of liver cancer in 10 patients with colorectal cancer in 10 patients with gastric cancer in 10 patients with esophageal cancer
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Liver cancer, colorectal cancer esophageal cancer gastric cancer patients
Cases can be ingested
Performance Status in ECOG (PS) 0 V - 1 case
Key exclusion criteria
Patients with serious complications
Cases have been complicated by cirrhosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
University of Tokushima
Division name
Department of Surgery
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9277
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokushima
Division name
Department of Surgery
Zip code
Address
TEL
088-633-9277
Homepage URL
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
University of Tokushima
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 01 | Day |
Last modified on
| 2011 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007209
