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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 | UMIN000022987 |
Receipt No. | R000026496 |
Scientific Title | Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy |
Date of disclosure of the study information | 2016/07/02 |
Last modified on | 2016/07/02 |
Basic information | ||
Public title | Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy | |
Acronym | Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy | |
Scientific Title | Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy | |
Scientific Title:Acronym | Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy | |
Region |
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Condition | ||
Condition | acute cholecystitis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of PTGBA for acute cholecystitis in patients with anti-thrombotic therapy. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Efficacy |
Key secondary outcomes | Procedure success rate
Safty |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | PTGBA | |
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) Patients with anti-thrombotic therapy
2) Moderate or severe acute cholecystitis 3) There is no recommend of emergency surgery 4) age =>20 |
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Key exclusion criteria | 1) No informed concent
2) Patients with mild cholecystitis 3) Patients with perforation of the gallbladder 4) Patients with pericholecystic abscess 5) Patients with gallbladder cancer 6) Patients with cholangitis 7) Ascitic fluid 8) Pregnancy 9) Cases regarded by doctors as inappropriate for the enrollment for some reasons |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kitasato University school of medicine | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan | ||||||
TEL | +81-42-778-8111 | ||||||
m-kida@kitasato-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kitasato University School of Medicine | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan | ||||||
TEL | +81-42-778-8111 | ||||||
Homepage URL | |||||||
kokuwaki@kitasato-u.ac.jp |
Sponsor | |
Institute | Department of Gastroenterology Kitasato University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | N/A |
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 | |
Address | |
Tel | |
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 | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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=R000026496 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |