UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036430 |
|---|---|
| Receipt number | R000041505 |
| Scientific Title | The effectiveness of esophageal peristaltic suppression using an intravenous drip of scopolamine butylbromide for endoscopic injection sclerotherapy of esophageal varices |
| Date of disclosure of the study information | 2019/04/06 |
| Last modified on | 2019/04/06 23:15:47 |
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Basic information
Public title
The effectiveness of esophageal peristaltic suppression using an intravenous drip of scopolamine butylbromide for endoscopic injection sclerotherapy of esophageal varices
Acronym
The effectiveness of esophageal peristaltic suppression using an intravenous drip of antispasmodic for endoscopic injection sclerotherapy of esophageal varices
Scientific Title
The effectiveness of esophageal peristaltic suppression using an intravenous drip of scopolamine butylbromide for endoscopic injection sclerotherapy of esophageal varices
Scientific Title:Acronym
The effectiveness of esophageal peristaltic suppression using an intravenous drip of antispasmodic for endoscopic injection sclerotherapy of esophageal varices
Region
| Japan |
Condition
Condition
esophageal varices
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We anticipated that use of an intravenous drip of scopolamine butylbromide might make the duration longer and the effectiveness of peristaltic suppression might improve.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fixation time of the puncture needle
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
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Patients who are enrolled will receive conventional sclerotherapy (1 week / week, 3 times a course), and both groups will first receive an intravenous injection of 10 mg of butylscopolamine bromide at the time of endoscope insertion as the first dose. In the continuous administration group, continuous intravenous administration was started immediately before puncture into the varicose vein with a drug solution in which 10 mg of butylscopolamine bromide was dissolved in 50 ml of physiological saline at a administration rate of 50 ml / hour.
Interventions/Control_2
In the intravenous group, an intravenous injection of 10 mg of butylscopolamine bromide was added at the need of the operator.
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 are considered for the treatment of esophageal varices, will undergo prophylactic sclerotherapy and meet the criteria below.
1 Men and women over 20 years of age
2Patients who perform endoscopic sclerotherapy prophylactically for esophageal varices
3 Patients who gave written informed consent and obtained written informed consent for study participation
Key exclusion criteria
1 Patients with hypersensitivity symptoms and contraindications in anticonvulsants used
2 Patients who are difficult to participate in this study due to the merger of serious liver disease, kidney disease, heart disease etc.
3 Pregnant women, lactating women or women who may be pregnant
4 Patients who are considered inappropriate by the research director or researcher for this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Akahoshi |
Organization
Iizuka Hospital
Division name
Gastroenterology
Zip code
820-8505
Address
3-83 Yoshio-machi, Iizuka , Japan.
TEL
0948-22-3800
ktokumaruh2@aih-net.com
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Sakai |
Organization
Iizuka Hospital
Division name
Gastroenterology
Zip code
820-8505
Address
3-83 Yoshio-machi, Iizuka , Japan.
TEL
0948-22-3800
Homepage URL
ktokumaruh2@aih-net.com
Sponsor or person
Institute
Iizuka Hospital,Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Iizuka Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iizuka Hospital
Address
3-83 Yoshio-machi, Iizuka , Japan.
Tel
0948-22-3800
ktokumaruh2@aih-net.com
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
| 2019 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041505
