UMIN-CTR Clinical Trial

Basic information
Public title	Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Acronym	Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Scientific Title	Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Scientific Title:Acronym	Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Region	Japan

Condition
Condition	benign lower intestinal stenosis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical effectiveness of endoscopic radial incision and cutting (RIC) for benign lower intestinal stenosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The patency rates at 52 weeks after RIC
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	RIC:Radial Incision and Cutting 1day.
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	benign lower intestinal stenosis through which a scope can't pass
Key exclusion criteria	Over 2cm lengths of stenosis. With surgical lesion such as stenosis or abscess With edematous stenosis, not fibrotic stenosis. With malignant stenosis. Woman with pregnancy, possibility of pregnancy. Woman who is within 28 days after postpartum. With psychiatric disorder With severe cardiopulmonary disorder The patients who the doctor judged as inappropriate.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Shiga
Organization	Tohoku University Hospital
Division name	Division of Gastroenterology
Zip code	980-8574
Address	1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7171
Email	shiga@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Rintaro Middle name Last name Moroi
Organization	Tohoku University Hospital
Division name	Division of Gastroenterology
Zip code	980-8574
Address	1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7171
Homepage URL
Email	rinta@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	self funding
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	Ethics Committee Tohoku University Hospital
Address	1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
Tel	022-728-4105
Email	ec@rinri.hosp.tohoku.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	2020 Year 02 Month 07 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	20
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	No longer recruiting
Date of protocol fixation	2020 Year 01 Month 28 Day
Date of IRB	2020 Year 02 Month 13 Day
Anticipated trial start date	2020 Year 02 Month 26 Day
Last follow-up date	2025 Year 01 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	2020 Year 02 Month 06 Day
Last modified on	2022 Year 02 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044929