Unique ID issued by UMIN | UMIN000012677 |
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Receipt number | R000011986 |
Scientific Title | Multicenter randomized control study for 4Fr naso biliary drainage. |
Date of disclosure of the study information | 2013/12/24 |
Last modified on | 2019/04/24 21:42:34 |
Multicenter randomized control study for 4Fr naso biliary drainage.
NBD4 study
Multicenter randomized control study for 4Fr naso biliary drainage.
NBD4 study
Japan |
obstructive jaundice, acute cholangitis
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate clinical efficacy of 4 Fr ENBD for obstructive jaundice and acute cholangitis.
Efficacy
Confirmatory
Pragmatic
Not applicable
Clinical efficacy of 4 Fr ENBD for obstructive jaundice and acute cholangitis
the VAS discomfort score, the rate of spontaneous catheter displacement, reduction effect of incidence of acute pancreatitis for naive papilla.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
Central registration
2
Treatment
Device,equipment |
4Fr Nasobiliary drainage catherter
6Fr Nasobiliary drainage catherter
20 | years-old | <= |
Not applicable |
Male and Female
The patient by whom consent is got in written form from the person himself or herself about participation of the this examination.
A case which needs biliary tract drainage for obstructive jaundice and acute cholangitis.
A case which reveals a bile cholestasis although there is no jaundice.
Less than 20 years old.
A case with a pregnant woman, a nursing mother or the possibility of pregnancy.
The past history of endoscopic biliary sphincterotomy or endoscopic papillary balloon dilatation.
A case with more than 3 times of the normal upper limit of serum pancreatic enzyme level before ERCP.
Acute pancreatitis.
Sphincter of Oddi dysfunction.
Pancreas divisum or malformation of pancreaticobiliary ducts.
A case that an endoscope can not reach at the duodenal papilla.
The past history of the upper gastrointestinal tract rebuilding operation except billoth 1.
A case undergoing endoscopic biliary sphincterotomy or endoscopic papillary balloon dilatation.
A case of placing other endoprosthesis.
A case of placing multiple endoprosthesis.
Liver cirrhosis.
Undergoing drainage for right bile duct
Allergy for polyurethane or ERCP contrast medium.
220
1st name | |
Middle name | |
Last name | Tamito Sasaki |
Hiroshima University Hospital
Department of Gastroenterology and Metabolism
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
082-257-5192
suiken@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Tomofumi Tsuboi |
Hiroshima University Hospital
Department of Gastroenterology and Metabolism
082-257-5192
082-257-5192
suiken@hiroshima-u.ac.jp
Department of Gastroenterology and Metabolism, Hiroshima University Hospital
None
Self funding
NO
2013 | Year | 12 | Month | 24 | Day |
Published
Completed
2013 | Year | 03 | Month | 21 | Day |
2013 | Year | 07 | Month | 03 | Day |
2013 | Year | 05 | Month | 01 | Day |
2016 | Year | 05 | Month | 01 | Day |
2016 | Year | 08 | Month | 01 | Day |
2013 | Year | 12 | Month | 24 | Day |
2019 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011986
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