UMIN-CTR Clinical Trial

Public title

A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)

Acronym

A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)

Scientific Title

A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)

Scientific Title:Acronym

A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)

Region

Japan

Condition

Colorectal neoplasms

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The rate of delayed bleeding after prophylactic clip closure

Key secondary outcomes

The severity of delayed bleeding
Timing of delayed bleeding
The rate of thromboembolism
Closure time, The number of clips, The rate of lesions which cannot be closed
The incidence rate of PECS
Duration of hospitalization
The rate of delayed perforation
The rate of all adverse events
The rate of adverse events associated with ESD

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

Prophylactic clip closure after colorectal ESD

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with colorectal neoplasms considered an indication for colorectal ESD.
2)Lesions not larger than 50mm in diameter.
3)Allow multiple ESD and /or endoscopic resection other than ESD scheduled at the same time
4)Age 20 or older at registration.
5)Performance Status (ECOG) is 0, 1 or 2.
6)Receiving anticoagulant therapy.
7)Preserved major organs functions (bone marrow, liver, kidney, lung etc.).
8)Written informed consent from the patient himself.

Key exclusion criteria

1)Lesions extending to the anal canal or ileocecal valve.
2)Have schedules to receive another endoscopic resection for colorectal neoplasms within 28 days after this ESD.
3)Have schedules to receive chemotherapy, radiation therapy or surgery within 28 days after this ESD.
4)Judged that registration or participation in this study is difficult due to a psychiatric disorder.
5)allergy to metal.
6)Otherwise determined by investigators to be unsuitable for participation in this study.

Target sample size

45

Name of lead principal investigator

1st name	Tetsuo
Middle name
Last name	Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3621

Email

takehara@gh.med.osaka-u.ac.jp

Name of contact person

1st name	Hideharu
Middle name
Last name	Ogiyama

Organization

Ikeda Municipal Hospital

Division name

Department of Gastroenterology

Zip code

563-8510

Address

3-1-18 Jyonan, Ikeda, Osaka, Japan

TEL

072-751-2881

Homepage URL

Email

hideharu-ogiyama@hosp.ikeda.osaka.jp

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Osaka University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka University Graduate School of Medicine

Address

2-2 Yamadaoka, Suita, Osaka, Japan

Tel

06-6879-5111

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

07

Month

04

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

Enrolling by invitation

Date of protocol fixation

2019

Year

05

Month

14

Day

Date of IRB

2019

Year

06

Month

11

Day

Anticipated trial start date

2019

Year

06

Month

11

Day

Last follow-up date

2024

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

05

Month

14

Day

Last modified on

2023

Year

11

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041830