UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety of liver surgery with No-Drain policy: a multicenter randomized controlled trial
Title of the study (Brief title)	No drain policy in liver surgery
Region	Japan

Condition
Condition	Elective hepatic resection without biliary reconstruction
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety after hepatic resection using Clavien-Dindo grading system comparing with and without drain
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Frequency of postoperative complication at or greater than Clavien-Dindo grade 3
Key secondary outcomes	Wound-related complication, total postoperative complication, biliary leakage, inflammatory indicator in blood and serum examination, duration of 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	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Placement of abdominal drain
Interventions/Control_2	Absent of abdominal drain
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) Undergoing elective hepatic resection without biliary reconstruction 2) ECOG performance status: 0-2 3) Unimpaired organ function: 1. WBC >= 2,000/mm3 2. Plt >= 50,000/mm3 3. T.Bil <= 2.0 mg/dL 4. Cre <= 1.5 mg/dL 4) Age: 20 years or older 5) Written informed consent
Key exclusion criteria	1) Concomitant resection of other organs excluding gallbladder 2) Administration of anti-coagulant drug just before the operation 3) Schedule to administrate anti-coagulant drug by 3 days after operation 4) Psychiatric disorder 5) Pregnant 6) Supposed extremely high risk of biliary leakage or bleeding after operation because of area of hepatic transection, and exposure of Glisson sheath on transection surface 7) C-tube placement 8) Thoracic tube placement
Target sample size	400

Research contact person
Name of lead principal investigator	Junichi Arita
Organization	Graduate School of Medicine, University of Tokyo
Division name	Hepatobiliary-Pancreatic Surgery Division, Department of Surgery
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, 135-8655
TEL	+81-3-3815-5411
Email	jarita-tky@umin.ac.jp

Public contact
Name of contact person	Junichi Arita
Organization	Graduate School of Medicine, University of Tokyo
Division name	Hepatobiliary-Pancreatic Surgery Division, Department of Surgery
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, 135-8655
TEL	+81-3-3815-5411
Homepage URL
Email	jarita-tky@umin.ac.jp

Sponsor
Institute	Hepatobiliary-Pancreatic Surgery Division, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs	YES
Study ID_1	P2015004-11Y
Org. issuing International ID_1	Research Ethics Committee, Graduate School of Medicine, University of Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 30 Day
Anticipated trial start date	2015 Year 06 Month 05 Day
Last follow-up date	2017 Year 09 Month 30 Day
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	2015 Year 05 Month 18 Day
Last modified on	2017 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020410