UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003324
Receipt number R000004038
Scientific Title Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection
Date of disclosure of the study information 2010/03/20
Last modified on 2016/02/10 11:32:08

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Basic information

Public title

Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection

Acronym

Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection

Scientific Title

Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection

Scientific Title:Acronym

Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection

Region

Japan


Condition

Condition

liver surgery

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the preventive effect for bleeding and biliary leakage, between fibrin sealing with PGA felt and collagen fleece on the liver cut surface.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Preventive effect for bleeding and biliary leakage

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Fibrin sealing with PGA felt

Interventions/Control_2

Collagen fleece

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

Liver surgery, written informed consent.

Key exclusion criteria

Allergy for the fibrin, PGA felt, collagen fleece.
Disability for communication with medical doctors.
Pregnancy
Others.

Target sample size

732


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Mori

Organization

Osaka University

Division name

Surgery

Zip code


Address

Yamadaoka 2-2E2

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Shogo Kobayashi

Organization

Osaka University

Division name

Surgery

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka University, Department of Surgery.

Institute

Department

Personal name



Funding Source

Organization

Osaka University

Organization

Division

Category of Funding Organization

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 20 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

J Am Coll Surg. 2015 Oct 23. pii: S1072-7515(15)01673-7. doi: 10.1016/j.jamcollsurg.2015.10.006. [Epub ahead of print]

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

2009 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 12 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



Management information

Registered date

2010 Year 03 Month 12 Day

Last modified on

2016 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004038


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name