UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018537 |
|---|---|
| Receipt number | R000019873 |
| Scientific Title | Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis |
| Date of disclosure of the study information | 2015/08/04 |
| Last modified on | 2020/05/28 13:30:08 |
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Basic information
Public title
Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis
Acronym
Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis
Scientific Title
Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis
Scientific Title:Acronym
Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis
Region
| Japan |
Condition
Condition
Non severe acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and the safety of immediate oral intake of low-fat solid diet in non severe acute pancreatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of days until the pancreatitis has recovered
Key secondary outcomes
length of hospital stay; hospitalization rate due to pancreatitis recurrence within three months after hospital discharge; number of days until the recurrence hospitalization; relapse rate of abdominal pain or abdominal symptoms during hospitalization period after meal initiation; proportion which mild acute pancreatitis became severe acute pancreatitis; dropout rate; reduction rate of serum levels of amylase, P-amylase, lipase and CRP; cost of hospital treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Gradually increase the amount of fat of diet after fasting with no food and drink
Interventions/Control_2
Permit oral intake of low-fat solid diet immediatly
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
| 16 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who diagnosed acute pancreatitis
Requires 2 of the following 3 features
1.upper abdominal pain of acute onset often radiating through to the back
2.serum amylase or lipase activity greater than 3 times the upper limit of normal
3.findings on cross sectional abdominal imaging consistent with acute pancreatitis.
Key exclusion criteria
1)Patients who diagnosed severe acute pancreatitis
2)Modified Marshall scoring system>=2
3)Patients who have a complication of cholangitis
4)Traumatic pancreatitis
5)Pancreatitis due to malignancy
6)Patients who are not able to eat solid food due to reduction of swallowing function
7)Patients who are not able to eat solid food due to consciousness disturbance
8)Patients with paralytic ileus
9)Patients who regularly take medicine for pain with chronic pancreatitis
10)Patients who did not subscribe in this study
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3790
takagast@z2.keio.jp
Public contact
Name of contact person
| 1st name | Masayasu |
| Middle name | |
| Last name | Horibe |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3790
Homepage URL
aries24sirius@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University Grant-in-Aid for Encouragement of Young Medical Scientists
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3611
med-rinri-jimu@adst.keio.ac.jp
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
慶應義塾大学病院（東京都）Keio University Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
http://www.keio-med.jp/gastro/pancreatitis-cohort/post-6.html
Publication of results
Published
Result
URL related to results and publications
http://www.keio-med.jp/gastro/pancreatitis-cohort/post-6.html
Number of participants that the trial has enrolled
26
Results
The immediate feeding group (mean recovery days: 2.0 +- 1.0) recovered significantly earlier (mean difference in recovery days: 6.3; 95% confidence interval [CI]: 4.8-7.9, p < 0.001) than the standard food group (mean recovery days: 8.3 +- 2.3).
Results date posted
| 2020 | Year | 05 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
mild acute pancreatitis
Participant flow
The patients in the immediate feeding group were permitted oral intake of low-fat (15 g/day) solid food (Figure A.1) immediately after diagnosis (within 1 day after diagnosis).
The patients in the standard group were given a gradually increasing amount of dietary fat following a fast in accordance with the Japanese guidelines
Adverse events
The immediate feeding group showed a lower rate of progression to severe AP (immediate feeding group, 0%; standard food group, 15.3%; p = 0.48).
Outcome measures
recovery days
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 04 | Day |
Last modified on
| 2020 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019873
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