UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012052 |
|---|---|
| Receipt number | R000014089 |
| Scientific Title | Prophylaxis and treatment Effects of Rikkunshito(TJ-43) on delayed gastric emptying (DGE) and gastrointestinal symptoms after pancreatoduodenectomy. |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2023/10/24 12:35:54 |
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Basic information
Public title
Prophylaxis and treatment Effects of Rikkunshito(TJ-43) on delayed gastric emptying (DGE) and gastrointestinal symptoms after pancreatoduodenectomy.
Acronym
The Effects of Rikkunshito on DGE and gastrointestinal symptoms after pancreatoduodenectomy.
Scientific Title
Prophylaxis and treatment Effects of Rikkunshito(TJ-43) on delayed gastric emptying (DGE) and gastrointestinal symptoms after pancreatoduodenectomy.
Scientific Title:Acronym
The Effects of Rikkunshito on DGE and gastrointestinal symptoms after pancreatoduodenectomy.
Region
| Japan |
Condition
Condition
Disease which needs to undergo pancreatoduodenectomy (carcinoma of the head of the pancreas, bile duct carcinoma, Papilla Vater carcinoma, duodenal carcinoma, etc.)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Rikkunshito(TJ-43) on DGE and gastrointestinal symptoms after pancreatoduodenectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence rate of DGE in patients underwent with pancreatoduodenectomy
Key secondary outcomes
1) Total dietary intake(TDI) after pancreatoduodenectomy
2) Gastrointestinal symptoms after pancreatoduodenectomy
3) The measurement of circulating gastrointestinal hormone(insulin, c-peptide, gastrin, glucagon and ghrelin)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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 Rikkunshito
(2.5g t.i.d) before meals for 21 days.
However, Rikkunshito(2.5g t.i.d) were administered as a diluent via enteral feeding tube on postoperative day 1-4.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients are scheduled to undergo pancreatoduodenectomy.
2) Performance Status(ECOG) of 0 to 1 cases.
3) Age:20<80
4) Sex, inpatient or outpatient: Not matter
5) All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria
1) Patient with active double cancer
2) Patient who has been undergoing chemotherapy
3) Patient who receives KAMPO medicine two weeks before treatment of rikkunshito
4) Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders)
5) Patient with serious hypersensitivity
6) Pregnancy or lactation woman. Patients who hope pregnancy during study
7) Patients considered inappropriate by the study investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Kimura |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and science
Zip code
Address
291-Nshi16, Minami1jo, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
kimuray@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Kimura |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and science
Zip code
Address
291-Nshi16, Minami1jo, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
kimuray@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
札幌医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014089
