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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019205
Receipt No. 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

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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
Email 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
Email hnitta@iwate-med.ac.jp

Sponsor
Institute The Japanese Endoscopic Liver Surgery Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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