UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039411
Receipt number R000044929
Scientific Title Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Date of disclosure of the study information 2020/02/07
Last modified on 2022/02/07 16:17:33

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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 or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044929


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name