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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034266
Receipt No. R000038983
Scientific Title The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study
Date of disclosure of the study information 2018/09/26
Last modified on 2018/09/26

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Basic information
Public title The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study
Acronym The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study
Scientific Title The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study
Scientific Title:Acronym The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study
Region
Japan

Condition
Condition Acute pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Emergency 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 patients with mild acute pancreatitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage diagnosed with moderately severe or severe by the revised Atlanta classification with day 4.
Key secondary outcomes Percentage diagnosed with severe by the revised Atlanta classification with day 4.
Percentage diagnosed with moderately severe or severe by the revised Atlanta classification during admission(within two weeks).
Percentage diagnosed with severe by the revised Atlanta classification during admission(within two weeks).
Percentage diagnosed as severe using the prognostic factor according to the severity criteria of the Ministry of Health, Labor and Welfare with day 4.
In-hospital mortality
In-hospital mortality due to pancreatitis
Number of days until disappearance of abdominal pain
Abdominal pain relapse rate
Number of days from diagnosis of pancreatitis to healing
length of hospital stay
The changes in CRP and Ca level(from day 0 to day 2 and from day 0 to day 4)
Cost
Hospitalization rate due to recurrence of pancreatitis within 4 weeks after discharge

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 Start low-fat solid food immediately (within 48 hours from diagnosis even if it is late) while allowing the use of an analgesics.
Interventions/Control_2 Gradually increase the amount of fat of diet after fasting with no food.
The criteria for starting meals shall satisfy all of the following 1) to 3).
1) An analgesic is not used for more than 24 hours.
2) Abdominal pain and abdominal tenderness are not prominent.
Abdominal pain is evaluated by WONG-BAKER Face (6 stages 0.2.4.6.8.10), and more than 6 is defined as prominent.
Abdominal tenderness WONG-BAKER Face (6 stages 0.2.4.6.8.10) is evaluated, and 6 or more is made prominent.
3) AMY is less than twice the standard upper limit of each facility
The standard for increasing the amount of lipid is the case where above 1) 2) is satisfied and the average intake amount of three meals of the same lipid amount is 50% or more.
Step 1:starvation
Steo 2:Form; not solid, fat; less than 5 g per day
Step 3:Form; any form, fat; 5 g or more and less than 15 g per day
Step 4:Form; solid, fat; 15 or more - 35 or less g per day
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 with acute pancreatitis

Requires 2 of the following three features
1.upper abdominal pain of acute onset often radiating through to the back
2.serum amylase or lipase activity greater than three times the upper limit of normal
3.findings on cross-sectional abdominal imaging consistent with acute pancreatitis.

The patients who had less than 2 points by Modified Marshall scoring system
Respiratory: PaO2/FiO2>=301
Renal: Creatinine<=1.8mg/dl
Cardiovascular: systolic blood pressure>=90mmHg or systolic blood pressure>=90mmHg with fluid responsive
Key exclusion criteria 1)Patients with pancreatitis caused by obstruction of the pancreatic duct and have not been resolved the obstruction
2)Patients who have a complication of cholangitis
3)Traumatic pancreatitis
4)Patients who are not able to eat solid food due to the reduction of swallowing function
5)Patients who are not able to eat solid food due to consciousness disturbance
6)Patients who can not expect sufficient dietary intake
7)Patients with paralytic ileus by CT or ultrasound
8)Patients who regularly take medicine for pain with chronic pancreatitis
9)Patient judged inappropriate for this study by the attending physician
10)Patients who are older than 1 week after the onset of pancreatitis
11) Patients who do not agree with this study
Target sample size 626

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Kanai
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3790
Email takagast@z2.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayasu Horibe
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
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 Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 26 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 18 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
2018 Year 09 Month 26 Day
Last modified on
2018 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038983

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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