UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016912 |
|---|---|
| Receipt number | R000018016 |
| Scientific Title | Evaluation of exocrine pancreatic function after esophagectomy and effect using pancrelipase |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2017/10/30 08:12:33 |
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Basic information
Public title
Evaluation of exocrine pancreatic function after esophagectomy and effect using pancrelipase
Acronym
Exocrine pancreatic function after esophagectomy and effect of pancrelipase
Scientific Title
Evaluation of exocrine pancreatic function after esophagectomy and effect using pancrelipase
Scientific Title:Acronym
Exocrine pancreatic function after esophagectomy and effect of pancrelipase
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of pancrelipase after operation of esophageal cancer who has low exocrine pancreatic function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The ratio of frequency of the stool below two times a day.
The ratio of bristol scale below 4.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
orally taking pancrelipase
terms: three months
amounts: 600mg/meal
times: ever time after meal
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) Esophageal cancer patients who is after esophagectomy and coming for follow-up visit.
2) Patients with lower fecal elastase1 than 200mg/g and has higher Bristol scale than 6.
3) Patients who had got informed consent.
Key exclusion criteria
1)Patients who is treating by chemotherapy or radiotherapy.
2)Patients who are allergic to swine protein.
3)Patients who had over 5kg of weight movement.
4)Patients who has a possibility of pregnant or now pregnant, or while nursing.
5)Patients with severe infection.
6)Patients who did not give consent to this research.
7)Patients who are suspected of chronic pancreatitis, after pancreatectomy and other cause of exocrine pancreatic dysfunction.
8)Patients with dyschezia caused by irritable bowel syndrome or inflammatory bowel disease.
9)Patients treated by enteral alimentation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kakeji |
Organization
Kobe University
Division name
Division of Gastrointestinal Surgery
Zip code
Address
Kusunoki-chou 7-5-2, Chuo-ku, Kobe
TEL
078-382-5925
kakeji@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Nakamura |
Organization
Kobe University
Division name
Division of Gastrointestinal Surgery
Zip code
Address
Kusunoki-chou 7-5-2, Chuo-ku, Kobe
TEL
078-382-5925
Homepage URL
tetsun@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 25 | Day |
Last modified on
| 2017 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018016
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
