UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013993 |
|---|---|
| Receipt number | R000016303 |
| 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 anticoagulation therapy |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2016/07/05 16:14:19 |
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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 anticoagulation therapy
Acronym
PGA sheets and fibrin glue after ESD in patients on anticoagulation 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 anticoagulation therapy
Scientific Title:Acronym
PGA sheets and fibrin glue after ESD in patients on anticoagulation therapy
Region
| Japan |
Condition
Condition
The patients with gastrointestinal neoplasms within the indication of endoscopic submucosal dissection (ESD) and has been on anticoagulation therapy.
Classification by specialty
| Gastroenterology |
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 anticoagulation 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
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
| Medicine |
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients on anticoagulation therapy who will undergo ESD of gastrointestinal neoplasms and have given written informed consent to this study.
Key exclusion criteria
Those who have serious complications.
Those who are considered to be inappropriate for this study by doctors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakao |
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
| 1st name | |
| Middle name | |
| Last name | Naoyuki Yamaguchi |
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 or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
| 2014 | Year | 06 | Month | 01 | Day |
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
| 2014 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 28 | Day |
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
| 2014 | Year | 05 | Month | 19 | Day |
Last modified on
| 2016 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016303
