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Multicenter randomized control study for 4Fr naso biliary drainage.

Multicenter randomized control study for 4Fr naso biliary drainage. - NBD4 study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012677
Enrollment
220
Registered
2013-12-24
Start date
2013-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructive jaundice, acute cholangitis

Interventions

4Fr Nasobiliary drainage catherter 6Fr Nasobiliary drainage catherter

Sponsors

Department of Gastroenterology and Metabolism, Hiroshima University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy of 4 Fr ENBD for obstructive jaundice and acute cholangitis

Secondary

MeasureTime frame
the VAS discomfort score, the rate of spontaneous catheter displacement, reduction effect of incidence of acute pancreatitis for naive papilla.

Countries

Japan

Contacts

Public ContactTomofumi Tsuboi

Hiroshima University Hospital Department of Gastroenterology and Metabolism

suiken@hiroshima-u.ac.jp082-257-5192

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026