UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011458
Receipt number R000012249
Scientific Title The efficacy of modified hemostasis forceps for gastric ESD
Date of disclosure of the study information 2013/08/25
Last modified on 2019/12/18 23:28:24

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Basic information

Public title

The efficacy of modified hemostasis forceps for gastric ESD

Acronym

The efficacy of modified hemostasis forceps

Scientific Title

The efficacy of modified hemostasis forceps for gastric ESD

Scientific Title:Acronym

The efficacy of modified hemostasis forceps

Region

Japan


Condition

Condition

early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficasy of new hemostasis forceps for bleeding during gstric ESD

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

hemostatic time for initial bleeding

Key secondary outcomes

hemostatic time for all bleeding
procedure time
complication


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

Device,equipment

Interventions/Control_1

standard hemostasis forceps

Interventions/Control_2

modified hemostasis forceps

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1. early gastric cancer that meet the criteria for ESD proposed by Japanese Gastric Cancer Society(those with a preoperative diagnosis of differentiated type intramucosal cancer without ulcer findings; differentiated type intramucosal cancer that was no longer than 3cm in diameter with ulcer findings; differentiated-type minute invasive submucosal cancer (invasion less than 0.5mm below the muscularis mucosa) that was no longer than 3cm in diameter; and undifferentiated-type intramucosal cancer that was no longer than 2 cm in diameter without ulcer finding.)
2. tumor size less than 60mm in diameter

Key exclusion criteria

1. leison including ulcer
2. patient recieving antithrombotic medication
3. patients with severe liver cirrhosis
4. dialysis patient
5. patient with compromized blood clotting

Target sample size

66


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinwa Tanaka

Organization

Kobe University Hospital

Division name

Endoscopy

Zip code


Address

7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan

TEL

078-382-5111

Email

tanakas@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinwa Tanaka

Organization

Kobe University Hospital

Division name

Endoscopy

Zip code


Address

7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan

TEL

078-382-5111

Homepage URL


Email

tanakas@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2013 Year 08 Month 25 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/27648821

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/27648821

Number of participants that the trial has enrolled

57

Results

Hemostasis time for the first bleeding episode during ESD was 73.0 seconds for the Coagrasper and 21.5 seconds for the FD-Y0007 (p < 0.001). When all episodes of bleeding were included, hemostasis time was 56.8 seconds in the Coagrasper group and 25.5 seconds in FD-Y0007group (p < 0.0001). The frequency of adverse events (perforation: 3.4% vs. 7.1%; delayed bleeding: 0% vs. 0%) was not significantly different between the two groups.

Results date posted

2019 Year 12 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Coagraspergroup:29patients
Median age: 72years old
Male/Female: 20/9

FD-Y0007group 28patients
Median age:71years old
Male/Female: 18/10

Participant flow

Sixty-six patients were enrolled. After randomization, 33 patients were assigned to each group. Four patients in the Coagrasper group and 5 patients in the FD-Y0007 group were excluded because there were no bleeding episodes that required use of the hemostatic forceps. A total of 29 patients in the Coagrasper group and 28 patients in the FD-Y0007 group were analyzed

Adverse events

Perforation:
Coagrasper group 3.4%
FD-Y0007 group 7.1%

Delayed bleeding:
Coagrasper group 0%
FD-Y0007 group 0%

Outcome measures

The time required to obtain hemostasis, which was measured for the first episode of bleeding during ESD
The mean time to obtain hemostasis for all episodes of bleeding
The rate of achieving hemostasis in 2 or fewer grasping attempts
The procedure times
Adverse event

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 07 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry

2014 Year 07 Month 30 Day

Date trial data considered complete

2014 Year 10 Month 31 Day

Date analysis concluded

2014 Year 11 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 08 Month 12 Day

Last modified on

2019 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name