UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2016

Year

03

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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