UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003414
Receipt number R000003656
Scientific Title Efficacy of Seprafilm for prevention of postoperative adhesions after liver surgery: clinical study
Date of disclosure of the study information 2010/03/31
Last modified on 2015/10/22 15:20:43

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Basic information

Public title

Efficacy of Seprafilm for prevention of postoperative adhesions after liver surgery: clinical study

Acronym

Prevention of adhesions by Seprafilm after liver surgery

Scientific Title

Efficacy of Seprafilm for prevention of postoperative adhesions after liver surgery: clinical study

Scientific Title:Acronym

Prevention of adhesions by Seprafilm after liver surgery

Region

Japan


Condition

Condition

hepatocellular carcinoma and metastatic cancer of the liver

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of Seprafilm for the prevention of the postoperative adhesions in liver surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

adhesion scores, time and amount of the blood loss needed for dissecting the adhesions in reoperation of the liver in future

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

application of Seprafilm after hepatectomy for the treatment of hepatocellular carcinoma or metastatic liver tumors

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases of hepatectomy scheduled for the treatment of hepatocellular carcinoma or metastatic liver tumors in our department.

Key exclusion criteria

If the patient has peritonitis or infectious complications,
If the patient has the history of severe allergy,
If dissection of lymph node or other is requred, or
If the patients do not agree,
the patients will be excluded from this study.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiro Kokudo

Organization

Graduate School of Medicine, University of University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

kihase-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norihiro Kokudo

Organization

Graduate School of Medicine, University of University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Homepage URL


Email

kihase-tky@umin.ac.jp


Sponsor or person

Institute

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,Graduate School of Medicine, University of University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2010 Year 03 Month 31 Day


Related information

URL releasing protocol


Publication of results

Partially 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

Completed

Date of protocol fixation

2009 Year 12 Month 07 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2014 Year 12 Month 31 Day

Date trial data considered complete

2014 Year 12 Month 31 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 03 Month 31 Day

Last modified on

2015 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name