UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054851 |
|---|---|
| Receipt number | R000062497 |
| Scientific Title | A multicenter trial evaluating initial technical success rate and safety of endoscopic radial incision and cutting for benign stenosis of lower gastrointestinal tract |
| Date of disclosure of the study information | 2024/07/02 |
| Last modified on | 2024/07/02 15:56:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multicenter trial evaluating initial technical success rate and safety of endoscopic radial incision and cutting for benign stenosis of lower gastrointestinal tract
Acronym
TRIC study
Scientific Title
A multicenter trial evaluating initial technical success rate and safety of endoscopic radial incision and cutting for benign stenosis of lower gastrointestinal tract
Scientific Title:Acronym
A multicenter trial evaluating initial technical success rate and safety of endoscopic radial incision and cutting for benign stenosis of lower gastrointestinal tract(TRIC study)
Region
| Japan |
Condition
Condition
benign stenosis of lower gastrointestinal tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate initial results (technical success rate and efficacy)of endoscopic radial incision and cutting for benign stenosis of lower gastrointestinal tract in a prospective way
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
technical success rate of endoscopic radial incision and cutting
Key secondary outcomes
procedure time of RIC
Adverse event rate and breakdown of adverse event related to RIC
subanalysis based on the underlying etiology
comparing the technical success rate of RIC between the attending institution
improvement of subjective symptpms (using a visual analog scale)
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
endoscopic radial incision and cutting
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
benign stenosis of lower gastrointestinal tract thorough with a colonoscope or a balloon-assisted enteroscopy can not 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.
Thin wall at the stenosis site evaluated by ultra sound, computed tomography or magnetic resonance imaging
No drug withdrawal possible of anti-platelet drug and anti-coagulant drug
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
40
Research contact person
Name of lead principal investigator
| 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
rinta@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
rinta@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Ifammatory Bowel Diseases
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
Ethics Committee Tohoku University Hospital
Address
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
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
| 2024 | Year | 07 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062497
