UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005056 |
|---|---|
| Receipt number | R000006011 |
| Scientific Title | Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2012/05/29 18:38:21 |
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Basic information
Public title
Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Acronym
Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Scientific Title
Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Scientific Title:Acronym
Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Patients with pancreatic head tumors undergoing pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of TJ-100 Tsumura Daikenchuto extract granules for accompanying abdominal symptoms (abdominal bloating, etc.) in intestinal dysmotility following pancreaticoduodenectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Number of postoperative day to comfirm normal bowel sound.
2)Number of postoperative day to comfirm first flatus.
3)Abdominal circumference
4)Bowel gas image
Key secondary outcomes
1)QOL assessment by the GSRS Score (Japanese Version)
2)Postoperative cytokine and diamine oxidase(DAO) level in serum and ascites
3)Incidence of postoperative intestinal obstruction
4)Incidence of postoperative complications
5)Postoperative length of stay
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
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 or after meals between preoperative day3 to postoperative day7
Interventions/Control_2
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)PS(ECOG Performance Status Scale):0-2
2)Patients who are diagnosed as abdominal pain or distention CTCAE≥1 by the attending physician preoperatively (when they provide written informed consent)
3)Patients who is able to have oral intake of the test drugs
4)Age: 20 years or older
5)Gender: no specification
6)2weeks or more blank after therapy is needed in case of receiving chemoradiotherapy
7)Adequate organ function and operable patient
8)Patients who can provide written informed consent
Key exclusion criteria
1)Patients with ischemic heart disease requiring treatment
2)Patients with liver cirrhosis or active hepatitis
3)Patients with interstitial pneumonitis or emphysema
4)Patients with chronic renal failure requiring dialysis
5)Patients with active duplicative malignant disease affecting adverse event
6)Patients who are scheduled to undergo pancreaticoduodenectomy together with other organs
7)Patients with history of intestinal resection
8)Patients who are administered another gastrointestinal prokinetic agents
9)Patients who need another Kampo medicines for medical treatment
10)Others, patients who are unfit for the study as determined by the attending physician
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Kawai |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama City, Wakayama Prefecture
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
TEL
Homepage URL
http://www.wakayama-med.ac.jp/med/2nd-surgery/index.html
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Tsumura company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 03 | 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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 08 | Day |
Last modified on
| 2012 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006011
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| Registered date | File name |
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