UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	The patients with gastrointestinal neoplasms within the indication of endoscopic submucosal dissection (ESD) and has been on antiplatelet 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 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	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

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	20 years-old <=
Age-upper limit	Not applicable
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.
Key exclusion criteria	Those who have serious complications. Those who are considered to be inappropriate for this study by doctors.
Target sample size	50

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
Email	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
Email	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
Email

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	2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 06 Month 01 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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016297

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