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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028950
Receipt No. 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

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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
Institute Nagasaki University
Institute
Department

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
URL(English) https://upload.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


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