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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018537
Receipt No. 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

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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
Email 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
Email aries24sirius@yahoo.co.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019873

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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