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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003020
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003665

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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