UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017452
Receipt number R000020093
Scientific Title Long-term outcome of laparoscopic hepatectomy in patients with hepatocellular carcinoma
Date of disclosure of the study information 2015/05/07
Last modified on 2015/05/07 15:36:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Long-term outcome of laparoscopic hepatectomy in patients with hepatocellular carcinoma

Acronym

LapHepHCC

Scientific Title

Long-term outcome of laparoscopic hepatectomy in patients with hepatocellular carcinoma

Scientific Title:Acronym

LapHepHCC

Region

Japan


Condition

Condition

310 consecutive patients who underwent primary hepatectomy between January 2001 and March 2010.

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To identify the long-term outcome of laparoscopic hepatectomy in patients with HCC, we analyzed the outcomes of 310 consecutive patients who underwent primary hepatectomy for HCC at our center.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The long-term outcome of laparoscopic hepatectomy in patients with HCC

Key secondary outcomes



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

34 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who can undergo hepatectomy

Key exclusion criteria

Patients who cannot undergo hepatectomy

Target sample size

310


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiya Kamiyama

Organization

Hokkaido Univerity

Division name

Gastroenterological Surgery I

Zip code


Address

N-15, W-7, Kita-ku, Sapporo

TEL

011-706-5927

Email

t-kamiya@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiya Kamiyama

Organization

Hokkaido University

Division name

Gastroenterological Surgery I

Zip code


Address

N-15, W-7, Kita-ku, Sapporo

TEL

011-706-5927

Homepage URL


Email

t-kamiya@med.hokudai.ac.jp


Sponsor or person

Institute

Gastroenterological Surgery I

Institute

Department

Personal name



Funding Source

Organization

Gastroenterological Surgery I

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 05 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2011 Year 03 Month 28 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To evaluate the long termprognosis for patients with hepatocellular carcinoma who undergo laparoscopic hepatectomy compared with patients who undergo open hepatectomy.


Management information

Registered date

2015 Year 05 Month 07 Day

Last modified on

2015 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020093


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name