UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029407
Receipt number R000033586
Scientific Title Evaluation of exhaled carbon dioxide monitoring during endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography
Date of disclosure of the study information 2017/10/09
Last modified on 2022/09/24 22:07:25

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Basic information

Public title

Evaluation of exhaled carbon dioxide monitoring during endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography

Acronym

Evaluation of exhaled carbon dioxide monitoring during ERCP and EUS

Scientific Title

Evaluation of exhaled carbon dioxide monitoring during endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography

Scientific Title:Acronym

Evaluation of exhaled carbon dioxide monitoring during ERCP and EUS

Region

Japan


Condition

Condition

patients who undergo endoscopic retrograde cholangiopancreatography or endoscopic ultrasonography at Keio university hospital

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to determine whether capnographic monitoring reduces the incidence of hypoxemia during endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

incidence of hypoxemia (SpO2< 90%)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

standard monitoring

Interventions/Control_2

capnography added standard monitoring

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 who undergo endoscopic retrograde cholangiopancreatography or endoscopic ultrasonography at Keio university hospital.

Key exclusion criteria

Aged <20 years,required emergency procedures,used oxygen,pre-existing hypoxemia,NYHA class 4,ASA class 4 and 5,hypotension(systolic blood pressure < 90mmHg),cannot bite bite -block

Target sample size

250


Research contact person

Name of lead principal investigator

1st name Eisuke
Middle name
Last name Iwasaki

Organization

Keio university school of medcine

Division name

gastroenterology and hepatology

Zip code

1600016

Address

35 Shinanomachi,Shinjyuku-ku,Tokyo,Japan

TEL

0333531211

Email

iwaiwa2007@gmail.com


Public contact

Name of contact person

1st name Eisuke
Middle name
Last name Iwasaki

Organization

Keio university school of medcine

Division name

gastroenterology and hepatology

Zip code

1600016

Address

35 Shinanomachi,Shinjyuku-ku,Tokyo,Japan

TEL

0333531211

Homepage URL


Email

iwaiwa2007@gmail.com


Sponsor or person

Institute

Keio university school of medcine

Institute

Department

Personal name



Funding Source

Organization

NIHON KOHDEN CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine

Address

35 Shinanomachi,Shinjyuku-ku,Tokyo,Japan

Tel

03-3353-1211

Email

med-rinri-ft_pt@adst.keio.ac.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

慶應義塾大学病院


Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 09 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

2017 Year 09 Month 29 Day

Date of IRB

2017 Year 08 Month 10 Day

Anticipated trial start date

2017 Year 10 Month 16 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2022 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2017 Year 10 Month 03 Day

Last modified on

2022 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033586


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name