Unique ID issued by UMIN | UMIN000034266 |
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Receipt number | 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 | 2020/09/19 01:01:32 |
The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study
RAPID study
The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study
RAPID study
Japan |
Acute pancreatitis
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Emergency medicine |
Others
NO
To assess the efficacy and the safety of immediate oral intake of low-fat solid diet in patients with mild acute pancreatitis
Safety,Efficacy
Confirmatory
Percentage diagnosed with moderately severe or severe by the revised Atlanta classification with day 4.
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Food |
Start low-fat solid food immediately (within 48 hours from diagnosis even if it is late) while allowing the use of an analgesics.
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
16 | years-old | <= |
95 | years-old | >= |
Male and Female
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
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
626
1st name | Takanori |
Middle name | |
Last name | Kanai |
Keio University School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo
03-5363-3790
takagast@z2.keio.jp
1st name | Masayasu |
Middle name | |
Last name | Horibe |
Keio University School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo
03-5363-3790
aries24sirius@yahoo.co.jp
Keio University School of Medicine
Japan Science and Technology Agency
Japanese Governmental office
Ethics Committee, Keio University School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo
03-5363-3611
med-rinri-jimu@adst.keio.ac.jp
NO
2018 | Year | 09 | Month | 26 | Day |
Unpublished
Open public recruiting
2018 | Year | 09 | Month | 10 | Day |
2018 | Year | 09 | Month | 26 | Day |
2020 | Year | 09 | Month | 18 | Day |
2024 | Year | 03 | Month | 31 | Day |
2018 | Year | 09 | Month | 26 | Day |
2020 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038983
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