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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000002492 |
Receipt No. | R000002956 |
Scientific Title | Safety and Efficacy of a modified small-caliber-tip transparent hood in endoscopic decompression for obstructive colorectal cancer |
Date of disclosure of the study information | 2009/09/14 |
Last modified on | 2011/03/22 |
Basic information | ||
Public title | Safety and Efficacy of a modified small-caliber-tip transparent hood in endoscopic decompression for obstructive colorectal cancer | |
Acronym | Safety and Efficacy of a modified ST hood in endoscopic decompression for obstructive colorectal cancer | |
Scientific Title | Safety and Efficacy of a modified small-caliber-tip transparent hood in endoscopic decompression for obstructive colorectal cancer | |
Scientific Title:Acronym | Safety and Efficacy of a modified ST hood in endoscopic decompression for obstructive colorectal cancer | |
Region |
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Condition | |||
Condition | Obstructive left-sided colorectal cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Endoscopic decompression for obstructive colorectal cancer may become easier and more successful by using modified small-caliber-tip transparent hood than by using conventional hood. Comparison on success rate and procedure time in endoscopic decompression for obstructive colorectal cancer between conventional hood and modified ST hood. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Success rate and procedure time to pass the guide-wire through the colorectal stricture site. |
Key secondary outcomes | Safety of endoscopic decompression by using modified small-caliber-tip transparent hood. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Endoscopic decompression using modified ST hood (Replaced with conventional hood only if failure occurs with modified ST hood within a specified time). | |
Interventions/Control_2 | Endoscopic decompression using conventional hood (Replaced with modified ST hood only if failure occurs with conventional hood within a specified time). | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with colorectal obstruction caused by advanced cancer in the left colon. | |||
Key exclusion criteria | Patients who are under age or patients who informed consent cannot be obtained in person or from the surrogate.
Patients who are not candidates for colonoscopy because of concomitant severe infectious disease or underlying severe diseases such as respiratory, circulatory diseases, and etc. |
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Target sample size | 50 |
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Name of lead principal investigator |
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Organization | Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology | ||||||
Division name | Endoscopy Center | ||||||
Zip code | |||||||
Address | 3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498 | ||||||
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Public contact | |||||||
Name of contact person |
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Organization | Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology | ||||||
Division name | Endoscopy center | ||||||
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Address | |||||||
TEL | 0285-58-7539 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Jichi Medical University, Department of Medicine, Division of Gastroenterology and Hepatology |
Institute | |
Department |
Funding Source | |
Organization | Jichi Medical University, Department of Endoscopic Research and International Education (Funded by Fujifilm) |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Date of the first journal publication of results | |
Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Other | |
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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=R000002956 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |