UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028950
Receipt number R000031976
Scientific Title Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/10/08 13:36:19

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Basic information

Public title

Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.

Acronym

Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.

Scientific Title

Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.

Scientific Title:Acronym

Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.

Region

Japan


Condition

Condition

Abdominal pain or bloating after hepatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of daikenchuto on postoperative abdominal pain or bloating after hepatectomy, and to explore an effect of the drug on small intestinal mucosal injury after abdominal surgery by assessing DAO and GLP-2.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Patient assessment of Postoperative abdominal pain or bloating (NRS).

Key secondary outcomes

1. Postoperative hospital stay
2. Assessment of intestinal injury and nutritional status (DAO, GLP-2, RBP, TTR, Tf, Alb)
3. Liver function (AST, ALT, Al-P,GGTP, T-Bil, PT)
4. Incidence and rate of postoperative complications (Clavien-Dindo Classification)
5. Incidence and rate of postoperative infection (wound, intraperitoneal, respiratory, urinary tract and systemic infection)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral administration of Daikenchuto 5.0 g (2.5g/pack x 2 packs) per dose three times a day from postoperative day 1 to 14.

Interventions/Control_2

Non-treatment of daikenchuto.

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. Selection criteria at the time of obtaining informed consent
1) Patient who are scheduled to undergo hepatectomy (>= subsegmentectomy)
2) Liver Damage A
3) Age: >= 20 years
4) Patient who are orally take daikenchuto
5) Adeguate organ functions and operable patient
6) Patient who are provide written informed consent

2. Selection criteria at the time of enrollment
7) With abdominal pain or bloating on postoperative day 1
8) Patient who are enforced hepatectomy (>= subsegmentectomy)

Key exclusion criteria

1) Emergency surgery
2) With history of hepatectomy
3) Patient who have constitutional ICG excretory defect
4) With history of gastrointestinal surgery (excluding appendectomy)
5) Patient who are scheduled to enforce a gut surgery with hepatectomy (including biliary reconstruction)
6)With inflammatory bowel disease such as ulcerative colitis or Crohn disease (including anamnestic case)
7)With history of stoma
8)Patient who are scheduled for chemotherapy, radiation therapy or radiofrequency ablation therapy within 4 weeks before enrollment, during surgery or within 14 days after surgery (during individual study period)
9) Patient who took kampo medicine or lactobacillus preparation within 4 weeks before enrollment
10) Patient who are pregnancy, possibly pregnancy, considering pregnancy or lactating
11) Patient who are determined not applicable for the study by the physician

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Susumu Eguchi

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Surgery

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7316

Email

sueguchi@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaaki Hidaka

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Surgery

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7316

Homepage URL


Email

mahidaka@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

TSUMURA and Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 09 Month 01 Day

Last modified on

2018 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031976


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name