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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021470
Receipt No. R000024759
Scientific Title Study of drainage treatment reduces the effect of media transformer tape use after liver resection
Date of disclosure of the study information 2016/03/20
Last modified on 2016/03/15

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Basic information
Public title Study of drainage treatment reduces the effect of media transformer tape use after liver resection
Acronym Study of drainage treatment reduces the effect of media transformer tape use after liver resection
Scientific Title Study of drainage treatment reduces the effect of media transformer tape use after liver resection
Scientific Title:Acronym Study of drainage treatment reduces the effect of media transformer tape use after liver resection
Region
Japan

Condition
Condition Two central segmental resection without biliary tract reconstruction, before segmental resection, out of the inner zone resection, patients who participated in this study.
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Originally nitroglycerin is the adaptation to ischemic heart disease due to coronary vasodilation action, is said to have a powerful relaxant effect even for about Batch nipple at the same time, endoscopic sphincterotomy in the common bile duct stones until this changes in the treatment of: (endoscopic Sphincterotomy EST) or endoscopic papillary balloon dilatation endoscopic (endoscopic papillary balloon dilatation (EPBD), reporting to cut stone while preserving the nipple function is by nitroglycerin administration. at the same time, the side effects of nitroglycerin administration, Yongchuan et al., reported that there was no change in need of special treatment in lowering blood pressure and pulse rate both by intravenous nitroglycerin. based on these reports, after hepatectomy media reduces the biliary tract internal pressure by using a transformer tape, it can prevent leakage of bile, to verify whether a result, it is possible to postoperative drainage treatment to reduce the cases necessary thing
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complication rates that require drainage treatment after liver resection
Definition: state drain was placed in the liver dissection can not be removed after the operation on the 4th or later, or, there is a need for liver dissection surface re-puncture after drain removal frequency
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
Medicine
Interventions/Control_1 Patient out of the liver resection without a biliary tract reconstruction, the central 2 segmental resection, before segmental resection, for the inner zone resection, which was the same participated in the study of the drain treatment incidence by media transformer tape use after liver resection was. Gender unquestioned. Than surgery the day, one by one day media transformer tape 27mg, used 10 days to evaluate the bile leakage-hepatectomy Hanaremen incidence of infection that require post-operative drainage treatment, and complications incidence of past cases Compare
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Patient 1. Central 2 segmental resection without biliary tract reconstruction, before segmental resection, one of the inner zone resection, who participated in the research on the study of mitigation effect leakage bile by the media transformer tape 27mg use after liver resection
2. within four weeks prior to registration electrocardiogram, at heart echo, clinically, there is no abnormal findings, which is a problem case
3. general state Performance status is 0-1 cases
4. explained with reference to informed consent document to the person about what the subject of the study, patients who consent in writing has been obtained
5. major organs (that meet all of the following in the registration within 14 days before testing) (heart, lung, liver, kidney, etc.) cases do not have a high degree of failure to function
- Total bilirubin: 2.0mg / dl or less
AST. ALT: 200 U / L or less
Hemoglobin: 9.0 g / dl or more
Serum creatinine :: facility upper limit of normal or less
- Systolic blood pressure is greater than or equal to 100mmHg patients (oral control possible)

Key exclusion criteria Media transformer tape 27mg use contraindicated condition (nitric acid-based drug hypersensitivity, angle-closure glaucoma, severe hypotension, cardiogenic shock, advanced anemia, head trauma) cases with
2. combination contraindicated drugs (drugs with a phosphodiesterase 5 inhibitory effect (sildenafil citrate (Viagra, Rebachio), vardenafil hydrochloride hydrate (Levitra), tadalafil (Cialis, Adoshiruka, Zarutia)), with a guanylate cyclase stimulating effect drug (Riociguat (Ademupasu))) cases in use
3. during surgery, patients were placed the C-tube
4. Others, has been determined to be inappropriate as a subject by the judgment of the practitioner case
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa takeda
Organization Yokohama City University Hospital
Division name Gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email kazutake@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhisa takeda
Organization Yokohama City University Hospital
Division name Gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email kazutake@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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 横浜市立大学附属市民総合医療センター 
国立病院機構横浜医療センター 
済生会横浜市南部病院
済生会若草病院 
伊東市民病院 
藤沢市民病院 
横須賀共済病院 
横須賀市立市民病院 
横浜掖済会病院 
横浜市立市民病院消化器 
横浜市立みなと赤十字病院 
横浜保土ヶ谷中央病院
長津田厚生総合病院

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 20 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 Preinitiation
Date of protocol fixation
2016 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 20 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
2016 Year 03 Month 15 Day
Last modified on
2016 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024759

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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