UMIN-CTR Clinical Trial

Public title

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-

Acronym

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-

Scientific Title

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-

Scientific Title:Acronym

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

Early colon cancer,Colon adenoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Name of contact person

1st name
Middle name
Last name	N

Organization

Nagasaki University Hospital

Division name

Department of GASTROENTEROLOGY and HEPATOLOGY

Zip code

Address

1-7-1 Sakamoto,Nagasaki

TEL

095-819-7489

Homepage URL

Email

naoyuki3334@hotmail.com

Institute

1-7-1 Sakamoto,Nagasaki

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2015

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

11

Month

30

Day

Date of IRB

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

Other related information

Registered date

2015

Year

03

Month

18

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=R000019535