UMIN-CTR Clinical Trial

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
Last 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
Email	ktokumaruh2@aih-net.com

Public contact
1st 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
Email	ktokumaruh2@aih-net.com

Sponsor
Institute	Iizuka Hospital,Gastroenterology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041505