UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021470
Receipt number 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 09:45:48

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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 or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



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

Value
https://center6.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