UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032660
Receipt number R000036998
Scientific Title Utility of emergency endoscopic drainage for patient with antithrombotic therapy.
Date of disclosure of the study information 2018/05/21
Last modified on 2020/05/21 09:48:03

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Basic information

Public title

Utility of emergency endoscopic drainage for patient with antithrombotic therapy.

Acronym

Endoscopic drainage for patient with antithrombotic therapy.

Scientific Title

Utility of emergency endoscopic drainage for patient with antithrombotic therapy.

Scientific Title:Acronym

Endoscopic drainage for patient with antithrombotic therapy.

Region

Japan


Condition

Condition

Patients with operable acute cholecystitis during antithrombotic therapy.
Patients with inoperable acute cholecystitis accompany with common bile duct stone.

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the appropriate endoscopic treatment: ETGBD and EUS-GBD for patients with acute cholecystitis who have no indication for emergency surgery because of antithrombotic therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficiency of ETGBD
Efficiency of EUS-GBD for patients who ETGBD was unsuccessful.
Disappearance of abdominal pain
Normalization of white blood cell count
Improvement of C-reactive protein value

Key secondary outcomes

Procedure success rate
Treatment time
Complication rate
Recurrence rate of cholecystitis


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

Maneuver

Interventions/Control_1

Treatment of ETGBD for patients with acute cholecystitis. In case of failure, PTGBD or EUS-GBD is alternatively performed.

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

98 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with acute cholecystitis requiring elective emergency drainage is necessary.
Patients who are not indicated for surgery or PTGBD due to poor general condition, oral antithrombotic drugs, elderly, etc.
Those are able to follow until cholecystectomy or inoperable.

Key exclusion criteria

Patients with multiple organ dysfunction
Patients with common bile duct stones
Pregnant, Female patient with potential for pregnancy or lactating

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Sagami

Organization

Oita San-ai Medical Center

Division name

Department of Gastroenterology

Zip code

870-1151

Address

1213, Oaza Ichi, Oita, Oita 870-1151, Japan.

TEL

+81-97-541-1311

Email

sagami1985@yahoo.co.jp


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Sagami

Organization

Oita San-ai Medical Center

Division name

Department of Gastroenterology

Zip code

870-1151

Address

1213, Oaza Ichi, Oita, Oita 870-1151, Japan.

TEL

+81-97-541-1311

Homepage URL


Email

sagami1985@yahoo.co.jp


Sponsor or person

Institute

Oita San-ai Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Oita San-ai Medical Center

Address

1213, Oaza Ichi, Oita, Oita 870-1151, Japan.

Tel

+81-97-541-1311

Email

sagami1985@yahoo.co.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

2018 Year 05 Month 21 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

Open public recruiting

Date of protocol fixation

2018 Year 04 Month 30 Day

Date of IRB

2018 Year 04 Month 30 Day

Anticipated trial start date

2018 Year 04 Month 30 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 21 Day

Last modified on

2020 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036998


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name