UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003020 |
|---|---|
| Receipt number | R000003665 |
| Scientific Title | Establishment of pancreatic exocrine function assaay usin real time 13C breath test. |
| Date of disclosure of the study information | 2010/01/13 |
| Last modified on | 2010/01/13 09:38:33 |
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Basic information
Public title
Establishment of pancreatic exocrine function assaay usin real time 13C breath test.
Acronym
Establishment of pancreatic exocrine function assaay usin real time 13C breath test.
Scientific Title
Establishment of pancreatic exocrine function assaay usin real time 13C breath test.
Scientific Title:Acronym
Establishment of pancreatic exocrine function assaay usin real time 13C breath test.
Region
| Japan |
Condition
Condition
Chronic pancreatitis, state after pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pancreas secretes digestive enzymes including amylase, lipase and trypsin according to the diet intake. Simultaneously, it secretes insulin, glucagon, gastrin and other hormones to help motility, blood sugar levels to organize total body nutrition. Human cannot live without its exocrine and endocrine function. If the endocrine function is impaired, diabetic condition is rationally treated by insulin by measuring blood glucose level. Exocrine function assessment, however, is only possible using classical fecal fat measurement, fecal chymotripsin or elastase I concentration or pancreatic functional diagnostic test. These assays are cumbersome and requires 24 hrs fecal collection or uurine collection. 13C is stable, non-radioactive isotope that can be incorporated into various compounds. We can measure the metabolism of such 13C incorporated compounds by measuring expiratory output of 13CO2. Most frequently used assay is expiratory 13C assay for Helicobacter pylori. The patients intakes the reagent and inflates the bag 15-20 min later to see if HP exists or eradicated.
It is already known that 13C incorporated fatty acids and amino acids are digested by pancreatic enzymes and finally metabolized to expiratory 13CO2. The measurement of expiratory 13CO2 is know to be useful as a pancreatic function assay (Swart GR, Digestion 1997; 8: 415-420, Nakamura H, Surgery 2009; 145:168-175). Breath ID is a realtime expiratory 13CO2 moniter, that is used in clinical situation in the Europe and United States not only for HP assay but also for measurement of liver function, pancreatic fuction and gastric emptying.
This research is aimed to establish the measurement of pancreatic fuction especially for chronic pancreatits and state after pancreatectomy using Breath ID and 13C incorporated fatty acids and amino acids, resulting in a better patient management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Expiratory 13CO2 concentration curve within 3 hours after oral intake of the reagents.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Expiratory 13CO2 measurement after oral intake of 13C incorporated fatty acids and amino acids in healthy volunteers.
Interventions/Control_2
Expiratory 13CO2 measurement after oral intake of 13C incorporated fatty acids and amino acids in patients after total pancreatectomy.
Interventions/Control_3
Expiratory 13CO2 measurement after oral intake of 13C incorporated fatty acids and amino acids in patients after pancreatico duodenectomy.
Interventions/Control_4
Expiratory 13CO2 measurement after oral intake of 13C incorporated fatty acids and amino acids in patients with chronic pancreatits.
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
Two Healthy volunteers, two patients after total pancreatectomy, two patients after pancreaticoduodenectomy, two patients with chronic pancreatitis.
Each participants should be in good health condition, not have active inflammation and available at out patients basis.
Basic blood test are within normal range or within the three times of upper limit.
Agreed to participate this trial with written informed consent.
Key exclusion criteria
One who has active malignancy or active inflammation.
Pregnat woman.
One who cannot eat.
One who cannot tolerate maximun three hours relaxed position with permission of rest for lavatories ad lib.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Egawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Dept. of Gastroenterological Surgery
Zip code
Address
1-1 Seiryo Aoba, Sendai, 980-8574, JAPAN
TEL
022-717-7205
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Egawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
1-1 Seiryo Aoba, Sendai, 980-8574, JAPAN
TEL
022-717-7205
Homepage URL
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare, JAPAN
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Science, Education, Culture, Sports, Science and Technology, JAPAN.
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
東北大学病院（宮城県） Tohoku University Hospital
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 13 | 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
| 2009 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 01 | Month | 13 | Day |
Last modified on
| 2010 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003665
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