UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031722
Receipt number R000036218
Scientific Title Comparative study on the usefulness of endoscopic retrograde gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage for inoperative cases with acute cholecystitis: Randomized controlled trial.
Date of disclosure of the study information 2018/03/20
Last modified on 2019/03/13 15:14:37

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Basic information

Public title

Comparative study on the usefulness of endoscopic retrograde gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage for inoperative cases with acute cholecystitis: Randomized controlled trial.

Acronym

Comparative study of endoscopic therapy for acute cholecystitis

Scientific Title

Comparative study on the usefulness of endoscopic retrograde gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage for inoperative cases with acute cholecystitis: Randomized controlled trial.

Scientific Title:Acronym

Comparative study of endoscopic therapy for acute cholecystitis

Region

Japan


Condition

Condition

inoperative acute cholecystitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the appropriate treatment for patients with acute cholecystitis who have no indication for emergency surgery via comparison of the efficacy and safety of ERGBD VS EUS-GBD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The Efficiency of each treatment
Disappearance of abdominal pain
Normalization of white blood cell count
Half 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

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Patients with acute cholecystitis treated by ERGBD.

Interventions/Control_2

Patients with acute cholecystitis treated by EUS-GBD.

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 with acute cholecystitis determined emergency drainage is necessary
Patients who are not indicated for surgery or PTGBD due to poor general condition, oral antithrombotic drugs, elderly, etc.
Those who are able to follow the passage of 60 days after treatment.

Key exclusion criteria

Patients with multiple organ dysfunction
Patients with common bile duct stones
Pregnant, Female patient with potential for pregnancy or lactating
Patients who are complicated with psychosis or psychiatric symptoms and seem to be difficult to participate in the study
Patients who are allergic to antibiotics

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryota Sagami

Organization

New Tokyo Hospital

Division name

Department of Gastroenterology

Zip code


Address

1271 Wanagaya, Matsudo Chiba, Japan

TEL

0477118700

Email

sagami1985@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryota Sagami

Organization

New Tokyo Hospital

Division name

Department of Gastroenterology

Zip code


Address

1271 Wanagaya, Matsudo Chiba, Japan

TEL

0477118700

Homepage URL


Email

sagami1985@yahoo.co.jp


Sponsor or person

Institute

New Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

New Tokyo Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Oita San-ai Medical Center

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

2018 Year 03 Month 20 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

2018 Year 03 Month 10 Day

Date of IRB

2018 Year 03 Month 10 Day

Anticipated trial start date

2018 Year 03 Month 10 Day

Last follow-up date

2018 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 03 Month 14 Day

Last modified on

2019 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036218


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name