UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006093
Receipt number R000007211
Scientific Title A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy and the evaluation of the incidence of bile reflux.
Date of disclosure of the study information 2011/08/01
Last modified on 2012/06/25 14:38:01

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Basic information

Public title

A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy and the evaluation of the incidence of bile reflux.

Acronym

A usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy and and the evaluation of the incidence of bile reflux.

Scientific Title

A prospective randomized controlled trial. The usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy and the evaluation of the incidence of bile reflux.

Scientific Title:Acronym

A usefulness of Braun anastomosis in the reconstruction after pancreaticoduodenectomy and and the evaluation of the incidence of bile reflux.

Region

Japan


Condition

Condition

pancreatic cancer, biliary cancer, duodenal cancer, pancreatic tumor, biliary tumor,duodenal tumor

Classification by specialty

Hepato-biliary-pancreatic surgery Adult

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 and evaluate of the incidence of bile reflux.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the incidence of the delayed gastric emptying

Key secondary outcomes

The hospital stay after surgery
Bile reflux, the incidence of other postoperative complications, pancratic fistula, intra-abdominal hemorrhage, and intra-abdominal abscess


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


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

Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Nagoya Medical University Hospital

Key exclusion criteria

1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent

Target sample size

68


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nagino Masato

Organization

Nagoya University Graduate School of Medicine

Division name

Division of Surgical Oncology, Department of Surgery

Zip code


Address

65 tsurumai-cho showa-ku Nagoya city

TEL

052-744-2222

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yokoyama Yukihiro

Organization

Nagoya University Graduate School of Medicine

Division name

Division of Surgical Oncology, Department of Surgery

Zip code


Address

65 tsurumai-cho showa-ku Nagoya city

TEL

052-744-2222

Homepage URL


Email

yyoko@med.nagoya-u.ac.jp


Sponsor or person

Institute

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine

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

2011 Year 08 Month 01 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

Enrolling by invitation

Date of protocol fixation

2011 Year 08 Month 02 Day

Date of IRB


Anticipated trial start date

2011 Year 08 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

2011 Year 08 Month 01 Day

Last modified on

2012 Year 06 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007211


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name