UMIN-CTR Clinical Trial
| Recruitment status | No longer recruiting |
| Unique ID issued by UMIN | UMIN000028783 |
| Receipt No. | R000032941 |
| Scientific Title | Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis |
| Date of disclosure of the study information | 2017/08/24 |
| Last modified on | 2020/02/24 (Ver. 5) |
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| Basic information | ||
| Public title | Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis | |
| Acronym | Efficacy and safety of duodenal stent
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| Scientific Title | Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis | |
| Scientific Title:Acronym | Efficacy and safety of duodenal stent
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| Region |
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| Condition | |||
| Condition | Gastric outlet obstruction due to malignancy | ||
| Classification by specialty |
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| Classification by malignancy | Malignancy | ||
| Genomic information | NO | ||
| Objectives | |
| Narrative objectives1 | To evaluate the efficacy and safety of duodenal stent for malignant gastric outlet obstruction |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Efficacy |
| Key secondary outcomes | Technical success rate
Safety |
| Base | |
| Study type | Observational |
| Study design | |
| Basic design | |
| Randomization | |
| Randomization unit | |
| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
| No. of arms | |
| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | 1. Gastric outlet obstruction due to malignancy
2. Written informed concent of the print. |
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| Key exclusion criteria | 1. Case with significantly poor general condition
2. Decision of unsuitableness by principal investigator. |
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| Target sample size | 30 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Yokohama City University Medical Center | ||||||
| Division name | Gastroenterological Center | ||||||
| Zip code | 232-0024 | ||||||
| Address | Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024,Japan | ||||||
| TEL | 045-261-5656 | ||||||
| sugimori@yokohama-cu.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Yokohama City University Medical Center | ||||||
| Division name | Gastroenterological Center | ||||||
| Zip code | 232-0024 | ||||||
| Address | Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024,Japan | ||||||
| TEL | 045-261-5656 | ||||||
| Homepage URL | |||||||
| miwa@yokohama-cu.ac.jp | |||||||
| Sponsor | |
| Institute | Yokohama CIty University Medical Center |
| Institute | |
| Department | |
| Funding Source | |
| Organization | None |
| 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 | Yokohama City University IRB |
| Address | 3-9Fukuura,Kanazawa-ku,Yokohama,Kanagawa |
| Tel | 045-787-2800 |
| nextjim1@yokohama-cu.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 | 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県) 横浜南共済病院(神奈川県) 済生会横浜市南部病院(神奈川県) 藤沢市民病院(神奈川県) |
| 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 | 31 | ||||||
| Results | Clinical success rate 87% Technical success rate 97% |
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| Results date posted |
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| Results Delayed |
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| Results Delay Reason | Submitting a paper | ||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Median age:70 Male 19 |
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| Participant flow | Duodenl stenting was performed for 31 cases |
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| Adverse events | Stent migration 1 Cholangitis 1 Delayed perforation 1 |
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| Outcome measures | Improvement of GOOSS |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | No longer recruiting | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | None |
| 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/icdr_e/ctr_view.cgi?recptno=R000032941 |
