UMIN-CTR Clinical Trial

Basic information
Public title	Study on safety for endoscopy and treatment by measuring intestinal pressure
Acronym	Study on safety for endoscopy and treatment by measuring intestinal pressure
Scientific Title	Study on safety for endoscopy and treatment by measuring intestinal pressure
Scientific Title:Acronym	Study on safety for endoscopy and treatment by measuring intestinal pressure
Region	Japan

Condition
Condition	The patient with small intestine disease and bilio pancreatic disease underwent ERCP, double balloon enteroscopy and double balloon assisted ERCP
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By measuring the intestinal pressure at the distal end of the endoscope, the safety of examination and treatment for the small intestine and postoperative reconstructed intestinal tract using double balloon endoscope is clarified.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the safety of examination and treatment for the small intestine and postoperative reconstructed intestinal tract using double balloon endoscope
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients underwent ERCP, double balloon enteroscopy, and double balloon assisted ERCP in Jichi Medical Univ.
Key exclusion criteria	The patients with acute abdominal condition The patients with acute severe inflammation Pregnant patients The patients with poor general condition The patients taking anticoagulant The patients with stenosis in the small intestine Patients judged to be inappropriate by the doctor in charge
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hironori Middle name Last name Yamamoto
Organization	Jichi Medical University
Division name	Department of Gastroenterology, Jichi Medical University
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL	0285-58-7348
Email	yamamoto@jichi.ac.jp

Public contact
Name of contact person	1st name Kensuke Middle name Last name yokoyama
Organization	Jichi Medical University
Division name	Department of Gastroenterology
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL	0285-58-7348
Homepage URL
Email	r0760ky@jichi.ac.jp

Sponsor
Institute	Department of Gastroenterology, Jichi Medical University
Institute
Department

Funding Source
Organization	FUJIFILM
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	Bioethics committee for clinical research A, Jichi medical university hospital
Address	3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
Tel	0285-58-7348
Email	rinri@jichi.ac.jp

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 12 Month 16 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	2018 Year 03 Month 22 Day
Date of IRB	2018 Year 03 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 22 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Clarify the safety of inspection and treatment of the small intestine and postoperative reconstructed intestinal tract by measuring the pressure in the intestinal tract at the distal end of the endoscope

Management information
Registered date	2019 Year 12 Month 16 Day
Last modified on	2019 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044350