UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial)
Title of the study (Brief title)	Drainage tube study at laparoscopic liver resection
Region	Japan

Condition
Condition	liver tumor
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Hidetoshi Eguchi
Organization	Graduate School of Medicine, Osaka University
Division name	Gastroenterological Surgery
Address	2-2 Yamadaoka, Suita 565-0871 Osaka, JAPAN
TEL	06-6879-3251
Email	heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Takehiro Noda
Organization	Graduate School of Medicine, Osaka University
Division name	Gastroenterological Surgery
Address	2-2 Yamadaoka, Suita 565-0871 Osaka, JAPAN
TEL	06-6879-3251
Homepage URL
Email	tnoda@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 09 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 20 Day
Last modified on	2017 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033398