UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of endoscopic tissue shielding method with polyglycolic acid (PGA) sheets and fibrin glue for the prevention of delayed bleeding after colorectal endoscopic submucosal dissection in patients taking antithrombotic therapy. -multicenter randomized control study-
Title of the study (Brief title)	The efficacy of endoscopic tissue shielding method with PGA sheets and fibrin glue for the prevention of delayed bleeding after colorectal endoscopic submucosal dissection in patients taking antithrombotic therapy. -multicenter randomized control study-
Region	Japan

Condition
Condition	Early colon cancer,Colon adenoma
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 antithrombotic therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Delayed bleeding
Key secondary outcomes	- intraoperative bleeding - resection with a tumor-free margin rate - curative resection rate - en bloc resection rate - incidence of perioperative thromboembolic event

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	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After colorectal ESD, enforce PGA felt + fibrin glue sealing method
Interventions/Control_2	After colorectal ESD, do not enforce PGA felt + fibrin glue sealing method
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	1.Early colon cancer or adenoma with adaptation lesions of ESD in the patients on antithrombotic therapy. 2.There is no significant metastasis clinically. 3.The patients who have given written informed consent to this study, and age at the time of the agreement acquisition is 20 years or older.
Key exclusion criteria	1. Patient who have double cancer (The cancer in situ or intramucosal carcinoma which can be cured completely by endoscopy operation, that is proper.) 2. Severe hepatic disorder, heart disease (myocardial infarction, angina, congestive heart failure, etc.), renal dysfunction 3. The patient who have severe infection. 4. Pregnant woman or with the possibility. The woman who is lactation period. 5. Severe bleeding or shock state 6. Patients with bleeding tendency. 7. Patients not elapsed patients or more than three months after the end of participating in another clinical trial. 8. Those who are considered to be inappropriate for this study by doctors.
Target sample size	300

Research contact person
Name of lead principal investigator	Kazuhiko Nakao
Organization	Nagasaki University Hospital
Division name	Department of Gastroenterology and hepatology
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7481
Email	kazuhiko@nagasaki-u.ac.jp

Public contact
Name of contact person	N
Organization	Nagasaki University Hospital
Division name	Department of GASTROENTEROLOGY and HEPATOLOGY
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7489
Homepage URL
Email	naoyuki3334@hotmail.com

Sponsor
Institute	1-7-1 Sakamoto,Nagasaki
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)

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	長崎医療センター 佐世保共済病院 戸畑共立病院 大分大学医学部附属病院 福岡大学筑紫病院 九州医療センター 佐賀県医療センター好生館 済生会熊本病院 鹿児島大学病院 宮崎大学医学部附属病院 東京医科大学病院 嬉野医療センター 鳥取大学医学部附属病院 鳥取県立中央病院 鳥取赤十字病院

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 11 Month 30 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 18 Day
Last modified on	2016 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019535