UMIN-CTR Clinical Trial

Public title

Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial)

Acronym

Drainage tube study at laparoscopic liver resection

Scientific Title

Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial)

Scientific Title:Acronym

Drainage tube study at laparoscopic liver resection

Region

Japan

Condition

liver tumor

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

For patients with liver tumor (hepatocellular carcinoma, metastatic liver cancer, benign tumor,etc.) adapted for laparoscopic hepatectomy (excluding biliary reconstruction, combined resection of other organs (excluding gallbladder excision)), comparison of short term results (within30 days)with and without preventive internal draining.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The rate of incidence of adverse event correlated with liver resection(bile leakage, bleeding, thoracicoabdominal fluid, intra-abdominal abscess, wound infection:more than Grade2 of Clavien-Dindo classification)

Key secondary outcomes

other adverse event, postoperative hospital stay

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

control group(drainage tube placement group)

Standards of treatment content
1)The type and number of drainage tube, the place of detention are not specified, but in principle the closed type drainage tube is used.
2)Criteria for withdrawal in drainage tube placement group:If the bilirubin level of drain fluid is less than 3 times the serum level around 3 days after surgery, it will be removed on the same day or the next day, the drain fluid level is not limited. When the drainage tube placement is extended, report the cause.
3)In cases where it is judged that drainage tube placement is necessary during operation after allocation to non drainage tube placement group, it is counted as non drainage tube placement group in which an adverse event occurred.
4)Diagnosis of bile leakage defines the bilirubin level of drain fluid to be more than 3 times the serum level. Leave it to the doctor in charge of each facility about the need for reoperation and additional drainage tube placement.
5)In case of laparotomy transition, protocol treatment is discontinued.

Interventions/Control_2

intervention group(non drainage tube placement group)

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)A patient with liver tumor that is indicated for laparoscopic hepatectomy(except biliary reconstruction).
2)A patient who have obtained written consent from participants in this study.
3)PS:0-1(ECOG grade)
4)A Patient found to have the function of the main organs by clinical examination within 28 days before registration.
5)Child-Pugh classification:A or B

Key exclusion criteria

1)A patient scheduled for other organ resection(excluding gallbladder) as combined resection.
2)A Patient who left bile drainage tube(C tube etc) during operation.
3)A patient with severe complications as follows.
intestinal palsy, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, heart failure, renal failure, liver failure, active ulcer of the gastrointestinal tract and active varicose veins, severe psychiatric disorders and depressive state.
4)A patient who is pregnant, has a possibility of pregnancy, is breastfeeding.
5)In addition, it is judged that the examination responsible doctor or the test sharing doctor is inappropriate as the subject of this examination.

Target sample size

350

Name of lead principal investigator

1st name
Middle name
Last name	Hidetoshi Eguchi

Organization

Graduate School of Medicine, Osaka University

Division name

Gastroenterological Surgery

Zip code

Address

2-2 Yamadaoka, Suita 565-0871 Osaka, JAPAN

TEL

06-6879-3251

Email

heguchi@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Takehiro Noda

Organization

Graduate School of Medicine, Osaka University

Division name

Gastroenterological Surgery

Zip code

Address

2-2 Yamadaoka, Suita 565-0871 Osaka, JAPAN

TEL

06-6879-3251

Homepage URL

Email

tnoda@gesurg.med.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2017

Year

09

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

2017

Year

09

Month

20

Day

Date of IRB

Anticipated trial start date

2017

Year

09

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

2017

Year

09

Month

20

Day

Last modified on

2017

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033398