Unique ID issued by UMIN | UMIN000009027 |
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Receipt number | R000010596 |
Scientific Title | Nafamostat Mesilate for prophylaxis of post-ERCP pancreatitis -A prospective, randomized, controlled, multicenter study - |
Date of disclosure of the study information | 2012/10/03 |
Last modified on | 2021/02/11 17:45:53 |
Nafamostat Mesilate for prophylaxis of post-ERCP pancreatitis
-A prospective, randomized, controlled, multicenter study -
NM for prophylaxis of post-ERCP pancreatitis
Nafamostat Mesilate for prophylaxis of post-ERCP pancreatitis
-A prospective, randomized, controlled, multicenter study -
NM for prophylaxis of post-ERCP pancreatitis
Japan |
Post-ERCP pancreatitis
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Others
NO
The aim of this study is to evaluate the efficacy of Nafamostat Mesilate for prophylaxis of post-ERCP pancreatitis. This study is a prospective, randomized, controlled, multicenter study.
Efficacy
Confirmatory
Not applicable
The incidence and severity of post-ERCP pancreatitis in the non-administration and the administration of Nafamostat Mesilate group.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
3
Prevention
Medicine |
Non-administration of Nafamostat Mesilate group
Nafamostat Mesilate administered before ERCP group.
Nafamostat Mesilate administered after ERCP group.
20 | years-old | <= |
Not applicable |
Male and Female
Patients who are planned ERCP with hospitalization.
1) Patients with agreement of this clinical study.
2) Aged 20 or over.
1) Patients without informed consent.
2) Patients who are not possible to communicate by mental disorder or disturbance of consciousness.
3) Patients who are pregnant or during pregnancy can not be ruled out.
4) Acute pancreatitis cases.
5) Patients with severe cardiopulmonary disease.
6) Patients who are received protease inhibitor within a week.
7) Patients with a history of allergy to iodine-based contrast agent and Nafamostat Mesilate.
8) Patients who are expected to be difficult to observe duodenal papilla endoscopically.
9) Endoscopic papillectomy cases.
10) Patients with Billroth-II and total gastrectomy.
11) Patients after treatment duodenal papilla EST, such as EPBD.
12) Patients who are judged inappropriate by medical examiner.
800
1st name | |
Middle name | |
Last name | Mitsuhiro Kida |
Kitasato University East Hospital
Dept. of Gastroenterology
2-1-1,Asamizodai,Minami-Ku
042-748-9111
m-kida@kitasato-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Imaizumi |
Kitasato University Hospital
Dept. of Gastroenterology
1-15-1,Kitasato,Minami-Ku,Sagamihara, Kanagawa
042-778-8111
imaizumi@yhc.att.ne.jp
Dept. of Gastroenterology, Kitasato University East Hospital
None
Self funding
NO
北里大学東病院(神奈川県)
Kitasato University East hospital (Kanagawa)
2012 | Year | 10 | Month | 03 | Day |
Unpublished
Completed
2012 | Year | 09 | Month | 12 | Day |
2012 | Year | 09 | Month | 12 | Day |
2012 | Year | 10 | Month | 03 | Day |
2021 | Year | 01 | Month | 31 | Day |
2012 | Year | 10 | Month | 02 | Day |
2021 | Year | 02 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010596
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