Unique ID issued by UMIN | UMIN000018537 |
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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 |
Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis
Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis
Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis
Benefit of immediate oral intake of low-fat solid diet in non severe pancreatitis
Japan |
Non severe acute pancreatitis
Hepato-biliary-pancreatic medicine |
Others
NO
To assess the efficacy and the safety of immediate oral intake of low-fat solid diet in non severe acute pancreatitis
Safety,Efficacy
The number of days until the pancreatitis has recovered
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
Gradually increase the amount of fat of diet after fasting with no food and drink
Permit oral intake of low-fat solid diet immediatly
16 | years-old | <= |
95 | years-old | >= |
Male and Female
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.
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
26
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
Keio University Grant-in-Aid for Encouragement of Young Medical Scientists
Other
Ethics Committee, Keio University School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo
03-5363-3611
med-rinri-jimu@adst.keio.ac.jp
NO
慶應義塾大学病院(東京都)Keio University Hospital(Tokyo)
2015 | Year | 08 | Month | 04 | Day |
http://www.keio-med.jp/gastro/pancreatitis-cohort/post-6.html
Published
http://www.keio-med.jp/gastro/pancreatitis-cohort/post-6.html
26
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).
2020 | Year | 05 | Month | 28 | Day |
mild acute pancreatitis
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
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).
recovery days
Completed
2015 | Year | 06 | Month | 18 | Day |
2015 | Year | 05 | Month | 25 | Day |
2015 | Year | 08 | Month | 04 | Day |
2019 | Year | 03 | Month | 31 | Day |
2015 | Year | 08 | Month | 04 | Day |
2020 | Year | 05 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019873
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