UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006093
Receipt No. 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

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

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
URL(English) https://upload.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


Contact us.