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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028355 |
Receipt No. | R000032452 |
Scientific Title | Avoidance of surgery with endoscopic balloon dilation and pharmacotherapy in obstructive small bowel Crohn's disease: a retrospective Japanese multicenter study |
Date of disclosure of the study information | 2017/07/24 |
Last modified on | 2020/01/25 |
Basic information | ||
Public title | Avoidance of surgery with endoscopic balloon dilation and pharmacotherapy in obstructive small bowel Crohn's disease: a retrospective Japanese multicenter study
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Acronym | Symptomatic obstructive small bowel Crohn's disease and intestinal resection | |
Scientific Title | Avoidance of surgery with endoscopic balloon dilation and pharmacotherapy in obstructive small bowel Crohn's disease: a retrospective Japanese multicenter study
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Scientific Title:Acronym | Symptomatic obstructive small bowel Crohn's disease and intestinal resection | |
Region |
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Condition | ||
Condition | Crohn's disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the relationship between symptomatic small intestinal stricture and intestinal resection of Crohn's disease |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Cumulative intestinal resection rate after onset of symptomatic stenosis |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Crohn's disease patients with previous consultation from January 1, 2008 to March 31, 2017
(i) Among patients diagnosed with Crohn's disease, those who developed stenotic symptoms for the first time from January 1, 2008 through March 31, 2017. (ii) Confirmation of gastrointestinal stricture is performed by balloon small intestine endoscopy, X-ray fluoroscopy, CT, capsule endoscopy examination, etc. |
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Key exclusion criteria | (i) Case in which intestinal resection is performed before symptomatic stenosis
(ii) Case diagnosed as adhesive ileus (iii) Case with fistula (iv) Patient who had an offer to refuse research cooperation (v) In addition, when the doctor judges it as inappropriate |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Shiga University of Medical Science | ||||||
Division name | Division of Gastroenterology | ||||||
Zip code | 520-2192 | ||||||
Address | Seta-Tsukinowa, Otsu | ||||||
TEL | 0775482217 | ||||||
sb@belle.shiga-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Shiga University of Medical Science | ||||||
Division name | Division of Gastroenterology | ||||||
Zip code | 520-2192 | ||||||
Address | Seta-Tsukinowa, Otsu | ||||||
TEL | 0775482217 | ||||||
Homepage URL | |||||||
sb@belle.shiga-med.ac.jp |
Sponsor | |
Institute | Shiga University of Medical Science |
Institute | |
Department |
Funding Source | |
Organization | Shiga University of Medical Science |
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 | Shiga University of Medical Science |
Address | Seta-Tsukinowa, Otsu |
Tel | 077548-2544 |
hqeiyo@belle.shiga-med.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 |
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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 | |
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Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Other | |
Other related information | retrospective study |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032452 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |