UMIN-CTR Clinical Trial

Public title

The outcomes of liver resection with hepatic vein reconstruction for liver tumor

Acronym

The outcomes of liver resection with hepatic vein reconstruction for liver tumor

Scientific Title

Short- and long-term outcomes of liver resection with hepatic vein reconstruction for liver tumors

Scientific Title:Acronym

Short- and long-term outcomes of liver resection with hepatic vein reconstruction for liver tumors

Region

Japan

Condition

Liver tumors invading to the hepatic veins

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This multicenter research is conducted as a project study of the Japanese Society of Hepato-Biliary-Pancreatic Surgery. The purpose is to analyze the surgical indications, techniques and short- and long-term outcomes in liver resections with hepatic vein reconstruction for liver tumors, leading to further stabilization of surgical outcomes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The association between the patency of reconstructed hepatic vein and the surgical outcomes

Key secondary outcomes

1.The presence or absence of postoperative liver failure and 90-day mortality
2.Overall survival
3.Recurrence-free survival

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

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Patients who underwent liver resection with hepatic vein reconstruction for liver tumors between January 2010 and December 2020
2.Pathological diagnosis of liver tumors is obtained.

Key exclusion criteria

There are no exclusion criteria.

Target sample size

200

Name of lead principal investigator

1st name	Hiroshi
Middle name
Last name	Sadamori

Organization

Fukuyama City Hospital

Division name

Department of Surgery

Zip code

721-8511

Address

5-23-1, Zao cho, Fukuyama, Hiroshima 721-8511, Japan

TEL

0849-41-5151

Email

sadamori1036@fchp.jp

Name of contact person

1st name	Hiroshi
Middle name
Last name	Sadamori

Organization

Fukuyama City Hospital

Division name

Department of Surgery

Zip code

721-8511

Address

5-23-1, Zao cho, Fukuyama, Hiroshima 721-8511, Japan

TEL

0849-41-5151

Homepage URL

Email

sadamori1036@fchp.jp

Institute

Department of Surgery, Fukuyama City Hospital

Institute

Department

Personal name

Hiroshi Sadamori

Organization

The 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

IRB of Fukuyama CIty Hospital

Address

5-23-1, Zao cho, Fukuyama, Hiroshima 721-8511, Japan

Tel

0849-41-5151

Email

shibyou-rinri@city.fukuyama.hiroshima.jp

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

2025

Year

04

Month

25

Day

URL releasing protocol

DOI: 10.1002/jhbp.12077

Publication of results

Published

URL related to results and publications

DOI: 10.1002/jhbp.12077

Number of participants that the trial has enrolled

187

Results

Grade C post-hepatectomy liver failure (PHLF) and in-hospital mortality were 3.2% and 1.6 %, respectively. The median overall survival (OS) and recurrence-free survival (RFS) were 49.9 and 9.8 months, respectively. Compared with HV reconstruction for securing liver remnant (LR) function (n=148), reconstruction of the only main HV remaining in the LR (n=39) had significantly worse short-term outcomes, but did not result in increased mortality, and showed equivalent OS and RFS.

Results date posted

2025

Year

04

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Regarding liver tumor types, 128 patients had CRLM, 27 had HCC, 27 had ICC, and 5 had other types of liver tumor. Preoperative chemotherapy (PCT) was performed in 115 cases (61.5%) and CRLM in particular had a higher rate of PCT (75.8%) compared with HCC and ICC. HV reconstruction types comprised wedge resection and primary suture in 27 cases, wedge resection and patch graft plasty in 59 cases, trunk resection and interposition of the graft in 81 cases, and trunk resection and direct anastomosis in 20 cases. The type of vascular graft used for HV reconstruction included autograft in 113 cases, cryopreserved homograft in 16 cases, and synthetic graft in 8 cases. Regarding the type of liver resection, CRLM had more cases of partial hepatectomy, and HCC and ICC had more cases of hemihepatectomy. In addition, ICC had more cases of trisectionectomy and IVC reconstruction compared with CRLM and HCC. IVC reconstruction was performed in 20 cases (10.7%).

Participant flow

Patients who were diagnosed as having liver tumors and who underwent liver resection with HV reconstruction between January 2010 and December 2020 were included in the study.

Adverse events

Obstruction of the reconstructed HV was associated with in-hospital mortality in 2 cases. Eight patients underwent invasive treatments for obstruction or stenosis of the reconstructed HV: thrombectomy plus re-anastomosis in 1 patient, re-anastomosis in 3 patients, and metallic stent placement in 4 patients. Two of these 8 patients died due to grade C PHLF as mentioned above, and one recovered from grade C PHLF.

Outcome measures

1.Operative and postoperative surgical outcomes: Regarding the grade of PHLF according to ISGLS criteria, grades B and C were observed in 35 cases (18.7%) and 6 cases (3.2%), respectively. Morbidity of CD grades IV and V were 5.3% and 1.6%, respectively. Ninety-day mortality and in-hospital mortality among all 187 patients were observed in 2 cases (1.1%) and 3 cases (1.6%), respectively. In all 3 cases with in-hospital mortality, the cause of death was PHLF. Additionally, obstruction of the reconstructed HV was associated with PHLF and death in 2 of 3 cases with in-hospital mortality.
2.Overall and recurrence-free survival: For all 187 patients, the median OS and RFS were 49.9 and 9.8 months, respectively. The 1-, 3- and 5-year OS and RFS rates were 93% and 45%, 65% and 27%, and 44% and 22%. The median OS of CRLM and HCC were 48.0 and 45.5 months, respectively, and the estimated median OS of ICC was not reached. The median RFS of CRLM, HCC, and ICC were 8.4, 11.9, and 20.0 months, respectively. There were no significant differences in OS and RFS among the 3 types of liver tumor.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2021

Year

11

Month

29

Day

Date of IRB

2021

Year

11

Month

29

Day

Anticipated trial start date

2022

Year

07

Month

01

Day

Last follow-up date

2023

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

There are no other information.

Registered date

2025

Year

04

Month

25

Day

Last modified on

2025

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055266