UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033687
Receipt number R000024589
Scientific Title An advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/07 20:14:13

* 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

An advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.

Acronym

An advantage of a triple-row stapler closure in DP

Scientific Title

An advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.

Scientific Title:Acronym

An advantage of a triple-row stapler closure in DP

Region

Japan


Condition

Condition

Patients who undergo distal pancreatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To prove an advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The frequency of the incidence of post operative pancreatic fistule after distal pancreatectomy

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

Device,equipment Maneuver

Interventions/Control_1

Using a triple-row stapler closure or hand-sewn suture in distal pancreatectomy.

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who have the planned distal pancreatectomy

Key exclusion criteria

1) Younger than 20years old
2) Patients with febrile
3) No written informed consent of the patients
4) Pregnancy or insufficient contraception
5) Doubtful understanding or contractual capacity of the patient
6)Patients seems inadequate for this study by investigators

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromichi Kawaida MD PhD

Organization

Faculty of Medicine, University of Yamanashi

Division name

First Department of Surgery

Zip code


Address

1110 Shimokato, Chyuo-shi, Yamanashi

TEL

055-273-7390

Email

hrkawaida@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromichi Kawaida

Organization

Faculty of Medicine, University of Yamanashi

Division name

First Department of Surgery

Zip code


Address

1110 Shimokato, Chyuo-shi, Yamanashi

TEL

055-273-7390

Homepage URL


Email

hrkawaida@yahoo.co.jp


Sponsor or person

Institute

First Department of Surgery ,Faculty of Medicine, University of Yamanashi

Institute

Department

Personal name



Funding Source

Organization

None

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

2018 Year 08 Month 08 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

Completed

Date of protocol fixation

2010 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2010 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

2018 Year 08 Month 08 Day

Last modified on

2018 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024589


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name