UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008047 |
|---|---|
| Receipt number | R000009468 |
| Scientific Title | Effect of antispasmodic drug on endoscopic ultrasonography-a multicencer randomized comparative trial |
| Date of disclosure of the study information | 2012/05/28 |
| Last modified on | 2013/11/22 17:39:53 |
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Basic information
Public title
Effect of antispasmodic drug on endoscopic ultrasonography-a multicencer randomized comparative trial
Acronym
Effect of antispasmodic drug on endoscopic ultrasonography-a multicencer randomized comparative trial
Scientific Title
Effect of antispasmodic drug on endoscopic ultrasonography-a multicencer randomized comparative trial
Scientific Title:Acronym
Effect of antispasmodic drug on endoscopic ultrasonography-a multicencer randomized comparative trial
Region
| Japan |
Condition
Condition
pancreatobiliary disease necessary for EUS or EUS-FNA
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the differece between EUS/EUS-FNA with and without antispasmodic drugs
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total examination time
Key secondary outcomes
(1)Vital signs before, during and after EUS/EUS-FNA
(2)Dose of sedative drugs
(3)10 point VAS score for endoscopists and (4)patients satisfaction in EUS/EUS-FNA
(5)Number of puncture and rate of aquisition of specimen in EUS-FNA
(6)Dose of additive antispasmodic drugs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
use of antispasmodic drugs
Interventions/Control_2
no use of antispasmodic drugs
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients aged 20 years and older
(2)Patients necessary for EUS/EUS-FNA
(3)Patients with informed consent for joining the present study
Key exclusion criteria
(1)Refusal to provide informed consent (2)Poor general status (performance status 4: completely disabled, cannot perform any self-care, and totally confined to the bed)
(3)Younger than age 20 years
(4)Incapability of insertion of echoendoscope
(5)Severe heart or pulmonary dysfunction (6)Pregnancy
(7)Use of antispasmodic drugs (within 12 h) before EUS/EUS-FNA
(8)Patients with bleeding tendency
(9)Patients with hemorrhagic colitis, glaucoma, benign prostat hyperplasia, paralytic ileus, pheocromocytoma or allergy for butylscoporamine or glucagon
(10)Judged inappropriate by a doctor
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kuwatani |
Organization
Hokkaido university hospital
Division name
Department of Gastroenterology
Zip code
Address
North14, West5, Kita-ku, Sapporo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hokkaido university hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university hospital
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
| 2012 | Year | 05 | Month | 28 | 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
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
| 2013 | Year | 02 | Month | 13 | Day |
Date trial data considered complete
| 2013 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 28 | Day |
Last modified on
| 2013 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009468
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
