UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Japanese Endoscopic Liver Surgery Study Group

Institute

Department

Personal name

Organization

The Japanese Endoscopic Liver Surgery Study Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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