UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020770
Receipt number R000023969
Scientific Title Feasibility and safety of initial endoscopic common bile duct stone removal for patients with acute cholangitis
Date of disclosure of the study information 2016/01/27
Last modified on 2016/01/27 21:39:56

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Basic information

Public title

Feasibility and safety of initial endoscopic common bile duct stone removal for patients with acute cholangitis

Acronym

Initial endoscopic common bile duct stone removal for patients with acute cholangitis

Scientific Title

Feasibility and safety of initial endoscopic common bile duct stone removal for patients with acute cholangitis

Scientific Title:Acronym

Initial endoscopic common bile duct stone removal for patients with acute cholangitis

Region

Japan


Condition

Condition

Common bile duct stone
Acute cholangitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the feasibility and safety of initial endoscopic common bile duct stone removal for patients with acute cholangitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Success rate of initial endoscopic common bile duct stone removal
The incidence of adverse events

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Common bile duct stone
Acute cholangitis
Endoscopic biliary drainage within 48 hours from the onset of acute cholangitis

Key exclusion criteria

Acute biliary pancreatitis
Postoperative intestinal reconstruction

Target sample size

31


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuya Kitamura

Organization

Showa University School of Medicine

Division name

Division of Gastroenterology, Department of Medicine

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo

TEL

03-3784-8535

Email

k.kitamura@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuya Kitamura

Organization

Showa University School of Medicine

Division name

Division of Gastroenterology, Department of Medicine

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo

TEL

03-3784-8535

Homepage URL


Email

k.kitamura@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University School of Medicine

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

2016 Year 01 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

2015 Year 06 Month 25 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study
Case control study
(Initial endoscopic common bile duct stone removal vs. Papalliative endoscopic common bile duct stone removal)
From April 2013 to December 2014


Management information

Registered date

2016 Year 01 Month 27 Day

Last modified on

2016 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023969


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name