UMIN-ICDS Clinical Trial

Public title

National survey of conditional cumulative incidence of complications following liver resection

Acronym

National survey of conditional cumulative incidence of complications following liver resection

Scientific Title

National survey of conditional cumulative incidence of complications following liver resection

Scientific Title:Acronym

National survey of conditional cumulative incidence of complications following liver resection

Region

Japan

Condition

Patients who underwent liver resection

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To identify changes over time in the risk of complications after liver resection and the optimal length of hospital stay after liver resection based on these changes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Clavien-Dindo Grade II or higher complications after liver resection

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Open and minimally invasive liver resection performed between January 1, 2014 and December 31, 2020
2) Liver resection for benign or malignant disease.
3) Liver resection with combined resection of bile duct, gallbladder, hepatic artery, hepatic vein, and portal vein.

Key exclusion criteria

1) Patients with insufficient clinical data
2) Combined resection of other organs (stomach, diaphragm, adrenal gland, etc.)
3) Emergency surgery such as trauma
4) Simultaneous resection of other organs (gastrectomy, colorectal resection, or resection of other organs) or concurrent RFA
5) Patients who do not wish to participate in the study
6) Other patients deemed inappropriate by the researchers

Target sample size

15000

Name of lead principal investigator

1st name	Kiyoshi
Middle name
Last name	Hasegawa

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

kihase-tky@umin.ac.jp

Name of contact person

1st name	Genki
Middle name
Last name	Watanabe

Organization

Osaka City General Hospital

Division name

Department of Hepato-Biliary-Pancreatic Surgery

Zip code

534-0021

Address

2-13-22 Miyakojima-hondori, Miyakojima-ku, Osaka, Japan

TEL

06-6929-1221

Homepage URL

Email

gewatanabe-ncd@umin.ac.jp

Institute

Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name

Organization

Japanese Society of Hepato-Biliary-Pancreatic Surgery

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5841-0818

Email

gewatanabe-ncd@umin.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医学部附属病院（東京都）
国立国際医療センター（東京都）
慈恵医大葛飾医療センター（東京都）
大垣市民病院（岐阜県）
福山市民病院（広島県）
東京医科歯科大学大学院医歯学総合研究科（東京都）
市立秋田総合病院（秋田県）
岐阜大学（岐阜県）
国立病院機構 岩国医療センター（山口県）
自治医科大学附属さいたま医療センター（埼玉県）
大阪市立総合医療センター（大阪府）
東京医科大学消化器外科分野　茨城医療センター（茨城県）
独立行政法人国立病院機構仙台医療センター（宮城県）
県立広島病院（広島県）
静岡県立静岡がんセンター（静岡県）
千葉大学（千葉県）
信州大学（長野県）
新潟大学（新潟県）
がん研有明病院（東京都）
奈良県総合医療センター（奈良県）
富山県立中央病院（富山県）
慶應義塾大学（東京都）
鹿児島市立病院（鹿児島県）
群馬大学（群馬県）
近畿大学（大阪府）
岩手医科大学（岩手県）
宮崎大学（宮崎県）
松田病院（岡山県）
福井県立病院（福井県）
いわき市医療センター（福島県）
和歌山県立医科大学（和歌山県）
伊那中央病院（長野県）
長岡中央総合病院（新潟県）
長崎大学（長崎県）
国立病院機構大阪医療センター（大阪府）
北野病院（京都府）
山口大学（山口県）
三重大学（三重県）
浦添総合病院（沖縄県）
獨協医科大学埼玉医療センター（埼玉県）
関西労災病院（兵庫県）

Date of disclosure of the study information

2023

Year

06

Month

03

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

2022

Year

12

Month

24

Day

Date of IRB

2023

Year

02

Month

24

Day

Anticipated trial start date

2023

Year

02

Month

24

Day

Last follow-up date

2025

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Preoperative data
1) Patient background: sex, age (at surgery), height (cm), weight (kg), American Society of Anesthesiologists physical status (ASA-PS), smoking history, past history, past history of previous abdominal surgery
2) Hepatitis virus infection, background liver, liver function (ICG-R15, Child-Pugh classification)
3) Comorbidities (hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, pulmonary emphysema, pulmonary infarction, whether or not anticoagulants or antiplatelet agents were taken)
4) Blood test: PLT, PT (%) or INR, Alb (mg/dl), GOT (IU/L), GPT (IU/L), TB (mg/dl), ICG (%), Cre (mg/dL), CRP (mg/dL)
5) Liver tumor lesion: location, disease, number of tumors, maximum tumor diameter
6) Preoperative treatment

Surgical data
Anatomical resection or not, repeat hepatectomy or not, procedures (partial resection, regional resection, hemihepatectomy, extended hemihepatectomy), approach (open, laparoscopic, robotic etc.), adding thoracotomy or not, bile duct resection reconstruction or not, portal vein resection reconstruction or not, arterial resection reconstruction or not, operation time, pringle time, intraoperative blood loss, and concentrated red blood cell transfusion, Other transfusions (fresh-frozen plasma, platelets), presence or absence of drainage tube

Postoperative data
Postoperative complications: According to the Clavien-Dindo classification, the details and date of occurrence of complications of Clavien-Dindo Grade II or higher (if there were multiple complications, each complication should be listed separately). Postoperative hospital stay, mortality within 90 days after surgery, and readmission within 90 days after surgery and reason for readmission.
Pathological findings: pathological diagnosis, maximum diameter of tumor, R status, and resection margins

Registered date

2023

Year

06

Month

02

Day

Last modified on

2023

Year

06

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058229