UMIN-CTR Clinical Trial

Basic information
Public title	Study of safety and efficacy of Endoscopic Ultrasonography with Jelly injection
Acronym	USJ Study
Scientific Title	Study of safety and efficacy of Endoscopic Ultrasonography with Jelly injection
Scientific Title:Acronym	USJ Study
Region	Japan

Condition
Condition	Gastrointestinal tract tumor and esophagogastric varix
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Study on the safety and effectiveness of endoscopically injecting OS-1 jelly as a pretreatment for ultrasonic endoscopy for patients with or suspected of gastrointestinal tumor or esophageal varices .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pre-treatment success rate of ultrasonic endoscopic examination
Key secondary outcomes	Serious adverse event

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	As a pretreatment for ultrasonic endoscope, inject up to 400 ml of OS-1 jelly in case of insufficient 5 minutes or 400 ml of water injection method.
Interventions/Control_2
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Ultrasonic endoscopy with a probe method is planned with tumors of the esophagus, stomach, duodenum, small intestine, or large intestine, or with or suspected esophageal varices.
Key exclusion criteria	1) Cases with occlusion or high stenosis in the gastrointestinal tract. 2) Patients with a history of aspiration pneumonia or suspected of deteriorating swallowing function. 3) A case in which it is judged that the risk of endoscopic examination complicates gastrointestinal diseases such as intestinal perforation and acute pancreatitis and the effectiveness is exceeded. 4) Cases in which respiratory circulation status is not stable due to respiratory diseases, cardiovascular diseases, etc. and it is judged that it is difficult to perform endoscopic examination safely. 5) Other cases that the person in charge judged inappropriate to participate in this exam.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hajime Takatori
Organization	Kanazawa University Hospital
Division name	Gastroenterology
Zip code
Address	13-1,Takara-machi,Kanazawa
TEL	076-265-2235
Email	takatori@m-kanazawa.jp

Public contact
Name of contact person	1st name Middle name Last name Takeshi Terashima
Organization	Kanazawa University Hospital
Division name	Gastroenterology
Zip code
Address	13-1,Takara-machi,Kanazawa
TEL	076-265-2235
Homepage URL
Email	hajimetakatori@gmail.com

Sponsor
Institute	Kanazawa University Hospital, Department of Gastroenterology
Institute
Department

Funding Source
Organization	Kanazawa University Hospital, Department of Gastroenterology
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
Address
Tel
Email

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	2017 Year 07 Month 14 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	2017 Year 07 Month 07 Day
Date of IRB	2017 Year 07 Month 14 Day
Anticipated trial start date	2017 Year 07 Month 10 Day
Last follow-up date	2018 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 10 Day
Last modified on	2019 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032110