UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016722 |
|---|---|
| Receipt number | R000019406 |
| Scientific Title | Sedation for pharyngeal examination with transoral endoscopy: a comparative study of no sedation, midazolam and pethidine hydrochloride |
| Date of disclosure of the study information | 2015/03/06 |
| Last modified on | 2016/01/18 09:00:31 |
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Basic information
Public title
Sedation for pharyngeal examination with transoral endoscopy: a comparative study of no sedation, midazolam and pethidine hydrochloride
Acronym
Sedation for pharyngeal examination with transoral endoscopy
Scientific Title
Sedation for pharyngeal examination with transoral endoscopy: a comparative study of no sedation, midazolam and pethidine hydrochloride
Scientific Title:Acronym
Sedation for pharyngeal examination with transoral endoscopy
Region
| Japan |
Condition
Condition
pharyngeal cancer
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of midazolam and pethidine hydrochloride for pharyngeal examination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The score of suitable quality images at the 5 points as follows: uvula, posterior wall of oropharynx, epiglottic vallecula, right pyriform sinus and left pyriform sinus
Key secondary outcomes
Pharyngeal observation time,
Visual analogue scale score for discomfort after the pharyngeal examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
no sedation
Interventions/Control_2
midazolam
Interventions/Control_3
pethidine hydrochloride
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with esophageal cancer or patients who have history of esophageal cancer
Key exclusion criteria
Patients with pharyngeal cancer or patients who have history of pharyngeal cancer
Patients with hematological abnormality
Patients with severe organ failure
Patients who have been judged as in appropriate for this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Ishihara |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
isihara-ry@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Yamasaki |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
Homepage URL
yasshifive@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
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
| 2015 | Year | 03 | Month | 06 | 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
| 2015 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 06 | Day |
Last modified on
| 2016 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019406
