Unique ID issued by UMIN | UMIN000020457 |
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Receipt number | R000023621 |
Scientific Title | Efficacy and safety of high dose VS low dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pnacreatitis:a randomized controlled multicenter trial |
Date of disclosure of the study information | 2016/01/06 |
Last modified on | 2017/09/15 13:15:10 |
Efficacy and safety of high dose VS low dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pnacreatitis:a randomized controlled multicenter trial
High and low trial
Efficacy and safety of high dose VS low dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pnacreatitis:a randomized controlled multicenter trial
High and low trial
Japan |
post ERCP pancreatitis
Hepato-biliary-pancreatic medicine |
Others
NO
Non inferiority of Low dose VS high dose rectal diclofenac for prevention of post ERCP pancreatitis
Efficacy
Confirmatory
Pragmatic
Not applicable
Non inferiority of Low dose VS high dose rectal diclofenac for prevention of post ERCP pancreatitis
severity of pancreatitis
adverse event
serum AMY level 2 hours and one day after ERCP
Spread of inflamation in serum AMY high level
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Dose comparison
2
Prevention
Medicine |
Rectal administration of 0.5mg/kg diclofenac within 30 min. after ERCP
Rectal administration of 1.0mg/kg diclofenac within 30 min. after ERCP
20 | years-old | <= |
Not applicable |
Male and Female
Patients who are scheduled to undergo ERCP and who undergo emergency ERCP from 8:00 to 17:30
emergency ERCP from 17:30 to 8:30
eGFR<50
choledocholithiasis with pancreatitis
aspirin induced asthma
pregnancy
Triamterene oral administration
<20age
shock vital
NSAIDs allergy
900
1st name | |
Middle name | |
Last name | Kusumoto Kiyonori |
Kyoto Katsura Hospital
Department of gastroenterology
Yamadahirao17,nisikyouku,Kyoto city,Japan
075-391-5811
kusumoto1024@gmail.com
1st name | |
Middle name | |
Last name | Kusumoto Kiyonori |
Kyoto Katsura Hospital
Department of gastroenterology
Yamadahirao17,nisikyouku,Kyoto city,Japan
075-391-5811
kusumoto1024@gmail.com
Kyoto Katsura Hospital
Kyoto Katsura Hospital
Other
Tango central hospital
NO
2016 | Year | 01 | Month | 06 | Day |
Unpublished
Open public recruiting
2015 | Year | 12 | Month | 25 | Day |
2016 | Year | 01 | Month | 05 | Day |
2016 | Year | 01 | Month | 06 | Day |
2017 | Year | 09 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023621
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