UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039859 |
|---|---|
| Receipt number | R000045458 |
| Scientific Title | Elimination of intractable gastrointestinal stricture |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2022/09/20 17:09:14 |
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Basic information
Public title
Usefulness and safety of clip-assisted endoscopic linear incision for intractable benign gastrointestinal stenosis
Acronym
Endoscopic linear incision for intractable gastrointestinal stenosis
Scientific Title
Elimination of intractable gastrointestinal stricture
Scientific Title:Acronym
Stenosis release
Region
| Japan |
Condition
Condition
Refractory benign gastrointestinal stenosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The common treatment for benign esophageal stenosis after surgery and endoscopic treatment is endoscopic ballon dilatation (EBD), but effective treatment for EBD resistance and intractable cases has been not established. Therefore, we devised a new stenosis release and clip-assisted endoscopic linear incision for intractable benign gastrointestinal stenosis, and examine its usefulness and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stenosis release rate [% of patients with improvement of dysphagia (up to Dysphagia score 1 or less), a subjective symptom at 24 weeks after the start of treatment (%): number of improved patients / total number of patients x100]
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
Clip-assisted endoscopic linear incision
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) more than 20 years old
2) Those who have agreed in writing to participate in this clinical study
3) Patients who have no residual cancer (R0) for benign esophageal stenosis after surgery and endoscopic treatment
(Confirmation has also been performed on CT, etc.)
4) Any post-operative reconstruction site and method
5) Dysphagia (Dysphagia score> 2) despite two or more sets of EBD (one set undergoes EBD more than once) with EBD as a pre-treatment for esophageal stenosis at least 1 month apart Patient with chief complaint.
* Regardless of chemotherapy, PSL oral history
Key exclusion criteria
1) Unable to obtain consent
2) When the length of the stenosis exceeds 11 mm or the preventive clip cannot be placed
3) Patients with mental illness or psychiatric symptoms who are judged to be difficult to conduct this clinical trial
4) Long axis stenosis length of 2 mm or more (confirmed by endoscopy and X-ray contrast)
5) Others who the doctor judged inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kobara |
Organization
Faculty of Medicine, Kagawa University
Division name
Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
0878912156
kobara@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Planning Investigator |
| Middle name | |
| Last name | General Affairs Division |
Organization
Faculty of Medicine, Kagawa University Hospital
Division name
Investigator
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
0878985111
Homepage URL
chosa@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki, Kita
Tel
0878985111
chosa@med.kagawa-u.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 | 03 | Month | 18 | 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
1
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
Terminated
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 01 | 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 | 03 | Month | 18 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045458
