UMIN-CTR Clinical Trial

Public title

Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer
(a randomized, double-blind, multi-center, placebo-controlled study)

Acronym

Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC40-1001)

Scientific Title

Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer
(a randomized, double-blind, multi-center, placebo-controlled study)

Scientific Title:Acronym

Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC40-1001)

Region

Japan

Condition

Primary or metastatic liver cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the effect of TJ-100 Tsumura Daikenchuto extract granules for accompanying abdominal symptoms (abdominal bloating, etc.) in intestinal dysmotility following resection of liver cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

1) Time to first defecation after nasogastric tube removal (hr)
2) Postoperative number of bowel movements per day
3) blood ammonia level(micro gram/dL)
4) CRP(mg/dL)

Key secondary outcomes

1) QOL assessment by the GSRS Score (Japanese Version)
2) ICG-R15(%)
3) Incidence of postoperative intestinal obstruction
4) Incidence of postoperative complications
5) postoperative length of stay

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral administration of test drug (Daikenchuto) 5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before meals.

Interventions/Control_2

Oral administration of test drug (placebo)5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before meals.

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) PS(ECOG Performance Status Scale):0-2
2) Patients who is able to have oral intake of the test drugs
3) Age: 20 years or older
4) Gender: no specification
5) 4weeks or more blank after therapy is needed in case of receiving chemotherapy or radiotherapy in the prior treatment
6) Adequate organ functions and operable patient
7) CRP <= 2mg/dL
8) Inpatient/Outpatient: Inpatient(study duration)
9) Patients who can provide written informed consent

Key exclusion criteria

1) Patients who are scheduled to undergo laparoscopic hepatectomy
2) Patients with history of hepatectomy
3) Patients with inflammatory bowel disease (ulcerative colitis, Crohn disease)(including anamnestic case)
4) Patients requiring emergency surgery
5) Patients with synchronous or metachronous gastric resection
6) Patients with synchronous colon resection
7) RFA in the remnant liver at the same time as excising hepatectomy
8) Patients with history of chemotherapy or radiotherapy within4weeks before surgery , history of perioperative chemotherapy or radiotherapy
9) Patients who are scheduled to undergo chemotherapy or radiotherapy within 10days after surgery
10) Patients who are administered another Kanpo medicines for medical treatment within 4weeks before the test drug administration
11) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
12) Patients undergoing biliary reconstruction
13) Patients who have a colostomy
14) Patients with history of resection of digestive canal
15) Constitutional selective defect in the hepatic transport of indocyanine green (ICG) ;Patients who are ICG intolerant
16) Synbiotics combination
17) Others, patients who are unfit for the study as determined by the attending physician

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuo Kusano

Organization

Non-Profit Organization (NPO); Japan Labour Health and Welfare Organization

Division name

KUSHIRO ROSAI HOSPITAL

Zip code

Address

13-23, Nakazono-cho, Kushiro, Hokkaido 085-8533, Japan

TEL

0154-25-7308

Email

Name of contact person

1st name
Middle name
Last name	Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Division name

Office

Zip code

Address

TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan

TEL

03-5627-7594

Homepage URL

http://www.jfmc.or.jp/

Email

jfmc-dc@jfmc.or.jp

Institute

Japanese Foundation for Multidisciplinary Treatment of Cancer

Institute

Department

Personal name

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

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

北海道大学病院(北海道)，札幌医科大学附属病院（北海道），釧路労災病院（北海道），弘前大学附属病院（青森県），岩手医科大学附属病院（岩手県），東北大学病院（宮城県），日立総合病院（茨城県），深谷赤十字病院（埼玉県），亀田総合病院（千葉県），君津中央病院（千葉県），東邦大学医療センター大森病院（東京都），慶應義塾大学病院（東京都），東京医科大学八王子医療センター（東京都），富山大学病院（富山県），藤田保健衛生大学（愛知県），藤田保健衛生大学坂文種報徳會病院（愛知県）京都大学附属病院（京都府），大阪府立成人病センター（大阪府），大阪市立大学附属病院（大阪府），大阪府立急性期・総合医療センター（大阪府），大阪大学（大阪府），大阪医科大学（大阪府），大阪南医療センター（大阪府），徳島大学（徳島県），九州大学病院（福岡県），飯塚病院（福岡県），久留米大学病院（福岡県），長崎大学（長崎県），熊本大学附属病院（熊本県），大分大学附属病院（大分県），鹿児島大学附属病院（鹿児島県）

Date of disclosure of the study information

2010

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://dx.doi.org/10.1007/s10147-014-0678-2

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

Completed

Date of protocol fixation

2010

Year

01

Month

14

Day

Date of IRB

Anticipated trial start date

2010

Year

02

Month

01

Day

Last follow-up date

2012

Year

01

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

01

Month

27

Day

Last modified on

2014

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003761