UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011507 |
|---|---|
| Receipt number | R000013464 |
| Scientific Title | The comparison of the effects on saliva secretion and gastric motility by between transnasal and transoral endoscopy |
| Date of disclosure of the study information | 2013/08/18 |
| Last modified on | 2013/08/17 13:20:33 |
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Basic information
Public title
The comparison of the effects on saliva secretion and gastric motility by between transnasal and transoral endoscopy
Acronym
saliva trial
Scientific Title
The comparison of the effects on saliva secretion and gastric motility by between transnasal and transoral endoscopy
Scientific Title:Acronym
saliva trial
Region
| Japan |
Condition
Condition
All diseases or symptoms those need upper gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing the saliva secretion and gastric motility in transnasal and transoral endoscopy, to get the evidence that anticholinergic reagents are not necessary in transnasal upper gastrointestinal endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
saliva weight during the procedure
gastric motility (contraction times of pyloric ring and antrum per 1 minute)
Key secondary outcomes
pain (by VAS scale and qestionnaire)
electrogastrogram
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
muscle injection of butylscoporamine bromide before the procedure by tranoral endoscopy
Interventions/Control_2
no muscle injection of butylscoporamine bromide before the procedure by tranoral endoscopy
Interventions/Control_3
no muscle injection of butylscoporamine bromide before the procedure by transnasal endoscopy
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
written informed consent
patients who need upper gastrointestinal endoscopy
patients who can be injected butylscoporamine bromide
Key exclusion criteria
patients who have severe injury on important organs such as heart, blood, kidney and liver.
patients who have allergy against lidocain or butylscoporamine bromide
patients who have histories of abdominal surgery
patients not proper for butylscoporamine bromide injection such as prostate hypertrophy, glaucoma or arrythmia
patients who have bleeding tendency
patients who are thought to be not proper for the trial by the concerned doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Matsushima |
Organization
Tokai University School of Medicine
Division name
Dept of Int Med (gastroenterology)
Zip code
Address
143 Shimo-Kasuya, Isehara, Japan
TEL
+81-463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Matsushima |
Organization
Tokai University School of Medicine
Division name
Dept of Int Med (gastroenterology)
Zip code
Address
143 Shimo-Kasuya, Isehara, Japan
TEL
+81-463-93-1121
Homepage URL
mmatsush@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Dept of Int Med (gastroenterology), Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 17 | Day |
Last modified on
| 2013 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013464
