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UMIN-CTR Clinical Trial |
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Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000013990 |
Receipt No. | R000016297 |
Scientific Title | The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy. |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2016/07/05 |
Basic information | ||
Public title | The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy. | |
Acronym | PGA sheets and fibrin glue after ESD in patients on antiplatelet therapy. | |
Scientific Title | The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy. | |
Scientific Title:Acronym | PGA sheets and fibrin glue after ESD in patients on antiplatelet therapy. | |
Region |
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Condition | ||
Condition | The patients with gastrointestinal neoplasms within the indication of endoscopic submucosal dissection (ESD) and has been on antiplatelet therapy. | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine safety of ESD and efficacy of endoscopic tissue shielding method with PGA sheets and fibrin glue for the prevention of post-ESD bleeding in patients taking antiplatelet agents. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | the rate of delayed bleeding
intraoperative bleeding |
Key secondary outcomes |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
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 |
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Interventions/Control_1 | Covering mucosal defects after ESD with PGA sheets and fibrin glue | |
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 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients on antiplatelet therapy who will undergo ESD of gastrointestinal neoplasms and have given written informed consent to this study.
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Key exclusion criteria | Those who have serious complications.
Those who are considered to be inappropriate for this study by doctors. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nagasaki University Hospital | ||||||
Division name | Department of Gastroenterology and hepatology | ||||||
Zip code | |||||||
Address | 1-7-1 Sakamoto,Nagasaki | ||||||
TEL | 095-819-7481 | ||||||
kazuhiko@nagasaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nagasaki University Hospital | ||||||
Division name | Department of Endoscopy | ||||||
Zip code | |||||||
Address | 1-7-1 Sakamoto,Nagasaki | ||||||
TEL | 095-819-7481 | ||||||
Homepage URL | |||||||
naoyuki3334@hotmail.com |
Sponsor | |
Institute | Nagasaki University Hospital |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
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 | |
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016297 |