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 | 2026/05/05 13:01:14 |
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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
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
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
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
https://onlinelibrary.wiley.com/doi/10.1002/jhbp.12110
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jhbp.12110
Number of participants that the trial has enrolled
250
Results
250 patients were enrolled without dropouts or missing data (control group: 125; capnography group: 125). There was no significant difference in the incidence of hypoxemia between the control and capnography groups (29.6% [37/125] vs. 26.4% [33/125]; p = .573). The estimated odds ratio was 0.925 (95% confidence interval: 0.708-1.208). The EtCO2 concentration was successfully captured without impeding endoscopic maneuvers from the beginning to the end of the procedure in all patients.
Results date posted
| 2026 | Year | 05 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients in Keio University Hospital undergoing ERCP or EUS-related procedures with CO2 insufflation under moderate CS were enrolled.
Participant flow
We registered patients who had given prior written consent to participate in the study.
Adverse events
There were no serious adverse events, such as death or respiratory failure, in either group
Outcome measures
The primary outcome, the incidence of hypoxemia (SpO2 < 90%), was 26.4% (33/125) in the capnography group and 29.6% (37/125) in the control group, with no significant difference between the two groups (p = 0.573)
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
| 2026 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033586
