UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001775
Receipt number R000002137
Scientific Title One Step EUS-guided Cholecystoenterostomy in High Risk Patients
Date of disclosure of the study information 2009/04/30
Last modified on 2009/03/15 17:16:10

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Basic information

Public title

One Step EUS-guided Cholecystoenterostomy in High Risk Patients

Acronym

One Step EUS-guided Cholecystoenterostomy in High Risk Patients; Simple and Modified technique

Scientific Title

One Step EUS-guided Cholecystoenterostomy in High Risk Patients

Scientific Title:Acronym

One Step EUS-guided Cholecystoenterostomy in High Risk Patients; Simple and Modified technique

Region

Asia(except Japan)


Condition

Condition

Patients who are diagnosed with acute cholecystitis unresponsive to conservative management and poor candidate for surgery

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the technical feasibility, efficacy, and safety of modified EUS-guided cholecystoenterostomy in patients with high surgical risk or malignant disease of advanced stage.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Clinical resolution of acute cholecystitis

Key secondary outcomes

Technical success and procedure related complications


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Simple modified EUS-guided cholecystoenterostomy

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

18 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patient over 18 years old
2. Patient with acute cholecystitis
3. Patient with severe debilitating co-morbidity
4. Patient with terminal malignant disease

Key exclusion criteria

1. No written informed consent
2. Patient with uncorrectable severe coagulopathy


Target sample size

7


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Do Hyun Park

Organization

Asan Medical Center

Division name

Departments of Gastroenterology

Zip code


Address

388-1 Pungnap-dong, Songpa-gu, Seoul 138-736, Korea

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Tae Jun Song

Organization

Asan Medical Center

Division name

Departments of Gastroenterology

Zip code


Address

388-1 Pungnap-dong, Songpa-gu, Seoul 138-736, Korea

TEL


Homepage URL


Email



Sponsor or person

Institute

Asan Medical Center

Institute

Department

Personal name



Funding Source

Organization

Asan Medical Center

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

2009 Year 04 Month 30 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

Terminated

Date of protocol fixation

2008 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 09 Month 01 Day

Last follow-up date

2009 Year 02 Month 01 Day

Date of closure to data entry

2009 Year 02 Month 01 Day

Date trial data considered complete

2009 Year 03 Month 01 Day

Date analysis concluded

2009 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 03 Month 15 Day

Last modified on

2009 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002137


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name