UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004757
Receipt number R000005658
Scientific Title A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.
Date of disclosure of the study information 2010/12/25
Last modified on 2015/06/22 14:55:53

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Basic information

Public title

A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.

Acronym

A usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.

Scientific Title

A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.

Scientific Title:Acronym

A usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy.

Region

Japan


Condition

Condition

All disease to be indicated for the pancreatoduodenectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the usefulness of the Braun anastomosis in the reconstruction after pancreaticoduodenectomy. A prospective randomized controlled trial is conducted to compare the incidence of complications with or without Braun anastomosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

An adverse event until a discharge

Key secondary outcomes

A late adverse event


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Reconstruction with Braun anastomosis after pancreaticoduodenectomy

Interventions/Control_2

Reconstruction without Braun anastomosis after pancreaticoduodenectomy

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

A case performed pancreaticoduodenectomy at Dept. of surgery, Nagasaki Univ. hospital

Key exclusion criteria

1:a case not reconstructed by child method.
2:a case with combined resection of other organs
3:a case with severe complications.
4:a case judged to be inappropriate for the participation of the study by the attending surgeon

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ono Shinichiro

Organization

Nagasaki University

Division name

Department of Surgery

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7316

Email

shinichi0320_com@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ono Shinichiro

Organization

Nagasaki University

Division name

Department of Surgery

Zip code


Address

1-7-1, Sakamoto, Nagasaki

TEL

095-819-7316

Homepage URL


Email

shinichi0320_com@yahoo.co.jp


Sponsor or person

Institute

Nagasaki University

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 12 Month 25 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

Open public recruiting

Date of protocol fixation

2010 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2011 Year 01 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 12 Month 20 Day

Last modified on

2015 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name