UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.
Title of the study (Brief title)	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	Susumu Eguchi
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Surgery
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7316
Email	sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person	Masaaki Hidaka
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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