UMIN-CTR Clinical Trial

Public title

Efficacy of Seprafilm for prevention of postoperative adhesions in repeat hepatectomy of recurrent liver tumors.
Prospctive Randomized Controlled Trial

Acronym

Efficacy of Seprafilm in repeat hepatectomy of recurrent liver tumors.

Scientific Title

Efficacy of Seprafilm for prevention of postoperative adhesions in repeat hepatectomy of recurrent liver tumors.
Prospctive Randomized Controlled Trial

Scientific Title:Acronym

Efficacy of Seprafilm in repeat hepatectomy of recurrent liver tumors.

Region

Japan

Condition

hepatocellular carcinoma or colorectal liver metastases

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness of Seprafilm for the prevention of the postoperative adhesions in liver surgery

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

adhesion time needed for dissecting the adhesions in reoperation of the liver in future

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

application of Seprafilm after hepatectomy for the treatment of hepatocellular carcinoma or metastatic liver tumors.
No application of Seprafilm after hepatectomy for the treatment of hepatocellular carcinoma or metastatic liver tumors.

Interventions/Control_2

After hepatic resection, patients in both groups will undergo enhanced computed tomography every 3-4 months.

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) Age over 20 years old at the
registration day.
2) ECOG Performance Status is 0-2.
3) Patients with liver damage A or B
4) Patients with primary or secondary
hepatectomy scheduled for
hepatocellular carcinoma diagnosed by
CT imaging
5) Patients with primary or secondary
hepatectomy scheduled for the
treatment of colorectal liver
metastases in our department.
6) The history of prior local therapy are
permitted if liver tumor are
resectable.
7) Patients have enough organ function
for study treatment within 14 days
before registration.
- neutrophil count: >=2,000/mm3,
<=10,000 /mm3
- platelet: >=50,000/mm3
- serum bilirubib level: <=1.5mg/dL
- PT(%): >=50%
- serum creatinine level: <=1.5mg/dL
- AST: <=100IU/L
- ALT: <=100IU/L
- albumin: >=3.0g/dL
8) Written informed consent

Key exclusion criteria

1) Severe comorbidity
2) Severe infectious disease
3) Pleural effusion, ascites fluid and
the pericardial fluid needing treatment
4) Patients with other primary
malignancies.
5) A past history of drug allergy (needs
continuation therapy)
6) Chronic systemic treatment of
corticosteroid
7) Bleeding tendency, coagulation
disorder, abnormality of coagulation
factor, or administered anticoagulant
8) Patients infected with human
immunodeficiency virus (HIV)/acquired
immunodeficiency syndrome (AIDS).
9) Patients during pregnancy, breast-
feeding, or at risk of becoming
pregnant.
10) Psychological disorder
11) Considered not appropriate for surgery
12) Patients considered inappropriate by
the study investigator

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Takayama Tadatoshi

Organization

Nihon University School of Medicine

Division name

Department of Digestive Surgery

Zip code

Address

30-1, Ohyaguchi kami-machi, Itabashi-ku, Tokyo 173-8610, Japan

TEL

03-3972-8111

Email

takayama.tadatoshi@nihon-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kanamoto Akira

Organization

Nihon University School of Medicine

Division name

Department of Digestive Surgery

Zip code

Address

30-1, Ohyaguchi kami-machi, Itabashi-ku, Tokyo 173-8610, Japan

TEL

03-3972-8111

Homepage URL

Email

kanamoto.akira@nihon-u.ac.jp

Institute

Department of Digestive Surgery, Nihon University School of Medicine

Institute

Department

Personal name

Organization

KAKEN PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo

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

日本大学医学部附属板橋病院（東京都）、東京大学医学部附属病院（東京都）

Date of disclosure of the study information

2014

Year

07

Month

11

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

Terminated

Date of protocol fixation

2014

Year

05

Month

27

Day

Date of IRB

2014

Year

07

Month

11

Day

Anticipated trial start date

2014

Year

07

Month

11

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

07

Month

02

Day

Last modified on

2019

Year

07

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016826