UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012677
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

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Basic information

Public title

Multicenter randomized control study for 4Fr naso biliary drainage.

Acronym

NBD4 study

Scientific Title

Multicenter randomized control study for 4Fr naso biliary drainage.

Scientific Title:Acronym

NBD4 study

Region

Japan


Condition

Condition

obstructive jaundice, acute cholangitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate clinical efficacy of 4 Fr ENBD for obstructive jaundice and acute cholangitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

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

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

4Fr Nasobiliary drainage catherter

Interventions/Control_2

6Fr Nasobiliary drainage catherter

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

220


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tamito Sasaki

Organization

Hiroshima University Hospital

Division name

Department of Gastroenterology and Metabolism

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN

TEL

082-257-5192

Email

suiken@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomofumi Tsuboi

Organization

Hiroshima University Hospital

Division name

Department of Gastroenterology and Metabolism

Zip code


Address

082-257-5192

TEL

082-257-5192

Homepage URL


Email

suiken@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Metabolism, Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 03 Month 21 Day

Date of IRB

2013 Year 07 Month 03 Day

Anticipated trial start date

2013 Year 05 Month 01 Day

Last follow-up date

2016 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 24 Day

Last modified on

2019 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name