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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003220
Receipt No. R000003900
Scientific Title Randomized clinical trial evaluating the need for nasogastric decompression after hepatic resection
Date of disclosure of the study information 2010/03/01
Last modified on 2013/02/21

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Basic information
Public title Randomized clinical trial evaluating the need for nasogastric decompression after hepatic resection
Acronym Randomized clinical trial evaluating the need for nasogastric decompression after hepatic resection
Scientific Title Randomized clinical trial evaluating the need for nasogastric decompression after hepatic resection
Scientific Title:Acronym Randomized clinical trial evaluating the need for nasogastric decompression after hepatic resection
Region
Japan

Condition
Condition liver disease
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluating the need for nasogastric decompression after hepatic resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative comprication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 patient with postoperative nasogastric decompression
Interventions/Control_2 patient without postoperative nasogastric decompression
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
80 years-old >=
Gender Male and Female
Key inclusion criteria patient scheduled for liver resection
Key exclusion criteria associated rejection of digestive organs
bilodigestive anastomosis
emergency surgery
right thoracic approach
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Imamura Hiroshi
Organization Juntendo University School of Medicine
Division name Department of Hepatobiliary-Pancreatic Surgery
Zip code
Address 2-1-1,hongo,bunnkyouku,tokyo,japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University School of Medicine
Division name Department of Hepatobiliary-Pancreatic Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Juntendo University School of Medicine
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 03 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 Completed
Date of protocol fixation
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2013 Year 01 Month 01 Day
Date of closure to data entry
2013 Year 01 Month 01 Day
Date trial data considered complete
2013 Year 01 Month 01 Day
Date analysis concluded
2013 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 21 Day
Last modified on
2013 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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