UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019205 |
|---|---|
| Receipt number | R000022193 |
| Scientific Title | Validation cohort study of surgical results on laparoscopic liver resection; a prospective multicenter study in Japan |
| Date of disclosure of the study information | 2015/10/02 |
| Last modified on | 2015/10/02 19:35:59 |
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Basic information
Public title
Validation cohort study of surgical results on laparoscopic liver resection; a prospective multicenter study in Japan
Acronym
Validation cohort study of surgical results on laparoscopic liver resection; a prospective multicenter study in Japan
Scientific Title
Validation cohort study of surgical results on laparoscopic liver resection; a prospective multicenter study in Japan
Scientific Title:Acronym
Validation cohort study of surgical results on laparoscopic liver resection; a prospective multicenter study in Japan
Region
| Japan |
Condition
Condition
Liver disease (Patients planned to undergo laparoscopic liver resection)
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validate the surgical results on laparoscopic liver resection with a prospective multicenter study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Volume of blood loss, Rate of conversion to open laparotomy
Key secondary outcomes
Surgical time, Length of hospital stay, Rate of postoperative complications
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 planned to undergo laparoscopic liver resection and obtained informed consent.
Key exclusion criteria
Patients not to obtain informed consent.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Kaneko, Go Wakabayashi |
Organization
Toho University School of Medicine, Ageo Central General Hospital
Division name
Department of Surgery
Zip code
Address
Oomori west 6-11-1, Oota-ku, Tokyo
TEL
03-3762-4151
hironori@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nitta |
Organization
Iwate Medical University School of Medicine
Division name
Department of Surgery
Zip code
Address
Uchimaru 19-1, Morioka city, Iwate
TEL
019-651-5111
Homepage URL
hnitta@iwate-med.ac.jp
Sponsor or person
Institute
The Japanese Endoscopic Liver Surgery Study Group
Institute
Department
Personal name
Funding Source
Organization
The Japanese Endoscopic Liver Surgery Study Group
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
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
| 2015 | Year | 10 | Month | 02 | 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
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | 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
a prospective multicenter study
cohort study
All patients, who are planned to undergo laparoscopic liver resection between 2015/10/2 and 2020/10/1, will be included in this study, if consents are obtained.
Registration
1)Before surgery
Sex, age, body height, body weight, BMI, payment, diagnosis, tumor location, tumor diameter, vascular invasion, lymph node involvement, extra-hepatic metastasis, infection disease, surgical method, experience of operator, history of surgery, PS, blood examination value, ascites, Child-Pugh score, ICG value, liver damage, difficulty score.
2)After surgery
Date of surgery, surgical method, number of tumor, other organ resection, pre-coagulation, surgical time, volume of blood loss, transfusion, drain, intra-operative accident, background of liver, pneumoperitoneum pressure, patient position, liver mobilization, Pringle method, hilar approach, intra-operative ultrasonography, lymph node dissection, biliary reconstruction.
3)After discharge
Curability, date of intake, date of walking, morbidity, re-operation, length of hospital stay, mortality.
Management information
Registered date
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2015 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022193
