UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044975
Receipt number R000051388
Scientific Title Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis
Date of disclosure of the study information 2021/07/28
Last modified on 2021/07/28 00:52:56

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis

Acronym

Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis

Scientific Title

Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis

Scientific Title:Acronym

Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis

Region

Japan


Condition

Condition

Choledocholithiasis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the prognosis after endoscopic biliary drainage for choledocholithiasis in cirrhotic and non-cirrhotic patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

30-day mortality rate

Key secondary outcomes

Total-bilirubin recovery rate


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients treated endoscopically for choledocholithiasis

Key exclusion criteria

Patients who refused to participate in this study
Patients who had undergone percutaneous drainage before endoscopic treatment

Target sample size

700


Research contact person

Name of lead principal investigator

1st name Naoya
Middle name
Last name Kato

Organization

Graduate School of Medicine, Chiba University

Division name

Gastroenterology

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba

TEL

043-222-7171

Email

kato.naoya@chiba-u.jp


Public contact

Name of contact person

1st name Shin
Middle name
Last name Yasui

Organization

Graduate School of Medicine, Chiba University

Division name

Gastroenterology

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba

TEL

043-222-7171

Homepage URL


Email

yasui_s@chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Chiba University

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

Chiba University Graduate School

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba

Tel

043-222-7171

Email

inohana-rinri@chiba-u.jp


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

2021 Year 07 Month 28 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

699

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

2020 Year 08 Month 04 Day

Date of IRB

2020 Year 09 Month 23 Day

Anticipated trial start date

2020 Year 09 Month 23 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective cohort study
Patients with choledocholithiasis who underwent endoscopic biliary drainage at Chiba University Hospital and Eastern Chiba Medical Center between January 2004 and December 2019


Management information

Registered date

2021 Year 07 Month 28 Day

Last modified on

2021 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051388


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name